<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01667536</url>
  </required_header>
  <id_info>
    <org_study_id>MIP-1404-201</org_study_id>
    <nct_id>NCT01667536</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology</brief_title>
  <official_title>A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Molecular Insight Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Molecular Insight Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and&#xD;
      performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic&#xD;
      lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI&#xD;
      were also assessed, as judged by histopathology results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm, open label study of approximately 100 high-risk prostate cancer&#xD;
      patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients&#xD;
      receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours&#xD;
      after injection. As standard of care, patients will undergo prostatectomy and extended pelvic&#xD;
      lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image&#xD;
      data will be evaluated for visible uptake and compared with histopathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.</measure>
    <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
    <description>For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes</measure>
    <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
    <description>For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland</measure>
    <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
    <description>For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined &quot;tissue-segments&quot;) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions</measure>
    <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
    <description>For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined &quot;tissue-segments&quot;) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.</measure>
    <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
    <description>Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.</measure>
    <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
    <description>Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Drug: 99mTc-MIP-1404</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug: 99mTc-MIP-1404</intervention_name>
    <description>A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
    <arm_group_label>Drug: 99mTc-MIP-1404</arm_group_label>
    <other_name>MIP-1404</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male aged 21 years or older.&#xD;
&#xD;
          -  Ability to provide signed informed consent and willingness to comply with protocol&#xD;
             requirements.&#xD;
&#xD;
          -  Biopsy confirmed presence of adenocarcinoma of the prostate gland.&#xD;
&#xD;
          -  At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score&#xD;
             of greater than or equal to 130.&#xD;
&#xD;
          -  Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.&#xD;
&#xD;
          -  Agree to use an acceptable form of birth control for a period of 7 days after the&#xD;
             99mTc MIP-1404 injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating would significantly delay the scheduled standard of care therapy.&#xD;
&#xD;
          -  Administered a radioisotope within 5 physical half lives prior to study drug&#xD;
             injection.&#xD;
&#xD;
          -  Have any medical condition or other circumstances that, in the opinion of the&#xD;
             investigator, would significantly decrease obtaining reliable data, achieving study&#xD;
             objectives or completing the study.&#xD;
&#xD;
          -  Have a contraindication for MR imaging.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Scherr, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Presbyterian Hospital-Cornell</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Karnes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kevin Slawin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Vanguard Urologic Research Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Keane, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edouard Trabulsi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University / Jefferson Urology Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Jarrard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Ellis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Judd Moul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Klein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glickman Urology &amp; Kidney Institute, Cleveland Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bertram Yuh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope National Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Joniau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Briganti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vita-Salute University San Raffaele</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paolo Gontero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikhail I Shkolnik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Petr A Karlov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Petersburg State Public Medical Institution: &quot;Clinical Oncological Center&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vsevolod B Matveev, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Public State Institution &quot;Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Boris Ya Alexeev, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moscow Oncology Research Institute n.a. P.A. Hertsen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergey V Mishugin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City Clinical Hospital # 57</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Oleg B Karyakin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal State Public Institution &quot;Medical Radiology Research Center&quot; of Healthcare Ministry and Social Development of Russian Federation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexander K Nosov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergey B Petrov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Milan Hora, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Plzen, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josef Stolz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Motol, Clinic of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vladimir Student, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Olomouc, Clinic of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marek Krolupper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Na Bulovce, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Pesl,, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>General University Hospital in Prague, Clinic of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roman Zachoval,, MD, PhD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomayer's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcin Matuszewski, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinical Centre, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henryk Zielinski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Plzen, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jerzy Sokolowski, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Provincial Specialist Hospital in Wroclaw, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tomasz Szydelko, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>4th Military Teaching Hospital and Polyclinic,</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geza Boszormenyi-Nagy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bajcsy-Zsilinszky Hospital, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Tenke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jahn Ferenc South Pest Hospital, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Istvan Buzogany, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peterfy Sandor Street Hospital, Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michiel Sedelaar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC St. Radboud Nijmegen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope National Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital - Cornell</name>
      <address>
        <city>New York City</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glickman Urology &amp; Kidney Institute, Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University / Jefferson Urology Associates</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Vanguard Urologic Research Foundation</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington School of Medicine</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Olomouc, Clinic of Urology</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plzen, Department of Urology</name>
      <address>
        <city>Plzen</city>
        <zip>30599</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital in Prague, Clinic of Urology</name>
      <address>
        <city>Prague</city>
        <zip>128 08</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayer's Hospital</name>
      <address>
        <city>Prague</city>
        <zip>140 59</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Motol, Clinic of Urology</name>
      <address>
        <city>Prague</city>
        <zip>15006</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Na Bulovce, Department of Urology</name>
      <address>
        <city>Prague</city>
        <zip>180 01</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bajcsy-Zsilinszky Hospital, Department of Urology</name>
      <address>
        <city>Budapest</city>
        <zip>8991</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterfy Sandor Street Hospital, Department of Urology</name>
      <address>
        <city>Budapest</city>
        <zip>H-1076</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jahn Ferenc South Pest Hospital, Department of Urology</name>
      <address>
        <city>Budapest</city>
        <zip>H1204</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vita-Salute University San Raffaele</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Turin</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC St. Radboud Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Centre, Department of Urology</name>
      <address>
        <city>Gdansk</city>
        <zip>80952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plzen, Department of Urology</name>
      <address>
        <city>Warsaw</city>
        <zip>00909</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>4th Military Teaching Hospital and Polyclinic,</name>
      <address>
        <city>Wroclaw</city>
        <zip>50981</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Provincial Specialist Hospital in Wroclaw, Department of Urology</name>
      <address>
        <city>Wroclaw</city>
        <zip>51124</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital # 57</name>
      <address>
        <city>Moscow</city>
        <zip>105077</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal Public State Institution &quot;Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Oncology Research Institute n.a. P.A. Hertsen</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Public Institution &quot;Medical Radiology Research Center&quot; of Healthcare Ministry and Social Development of Russian Federation</name>
      <address>
        <city>Obninsk</city>
        <zip>249036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197374</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Public Medical Institution: &quot;Clinical Oncological Center&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>198255</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czech Republic</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
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    <citation>Durkalski VL, Palesch YY, Lipsitz SR, Rust PF. Analysis of clustered matched-pair data for a non-inferiority study design. Stat Med. 2003 Jan 30;22(2):279-90. doi: 10.1002/sim.1385.</citation>
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  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>December 15, 2015</results_first_submitted>
  <results_first_submitted_qc>February 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 30, 2016</results_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PROSTATE CANCER</keyword>
  <keyword>HIGH-RISK</keyword>
  <keyword>PROSTATECTOMY SURGERY</keyword>
  <keyword>NEWLY DIAGNOSED</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Drug: 99mTc-MIP-1404</title>
          <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105">105 subjects comprised the safety popn, defined as all subjects who received an MIP-1404 injection.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Drug: 99mTc-MIP-1404</title>
          <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="105"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.2" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.</title>
        <description>For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.</description>
        <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
        <population>The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: 99mTc-MIP-1404</title>
            <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.</title>
          <description>For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.</description>
          <population>The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)</population>
          <units>% sensitivity</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2" lower_limit="89.2" upper_limit="97.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes</title>
        <description>For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.</description>
        <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
        <population>The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: 99mTc-MIP-1404</title>
            <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes</title>
          <description>For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.</description>
          <population>The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.</population>
          <units>% sensitivity</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="19.8" upper_limit="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland</title>
        <description>For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined &quot;tissue-segments&quot;) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.</description>
        <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
        <population>The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: 99mTc-MIP-1404</title>
            <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland</title>
          <description>For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined &quot;tissue-segments&quot;) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.</description>
          <population>The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)</population>
          <units>% sensitivity</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <units_analyzed>Prostate Segments</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Prostate Segments</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="519"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4" lower_limit="36.1" upper_limit="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions</title>
        <description>For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined &quot;tissue-segments&quot;) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.</description>
        <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
        <population>The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: 99mTc-MIP-1404</title>
            <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions</title>
          <description>For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined &quot;tissue-segments&quot;) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.</description>
          <population>The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)</population>
          <units>% sensitivity</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <units_analyzed>Lymph Node Segments</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph Node Segments</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="3.2" upper_limit="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.</title>
        <description>Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.</description>
        <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
        <population>All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: 99mTc-MIP-1404</title>
            <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging.</description>
          </group>
          <group group_id="O2">
            <title>Drug: 99mTc-MIP-1404 + MRI</title>
            <description>Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.</title>
          <description>Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.</description>
          <population>All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.</population>
          <units>% specificity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8"/>
                    <measurement group_id="O2" value="85.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.</title>
        <description>Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.</description>
        <time_frame>Within 3-6 hours of dosing SPECT/CT images will be taken</time_frame>
        <population>All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: 99mTc-MIP-1404</title>
            <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging.</description>
          </group>
          <group group_id="O2">
            <title>Drug: 99mTc-MIP-1404 + MRI</title>
            <description>Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.</title>
          <description>Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.</description>
          <population>All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.</population>
          <units>% sensitivity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 (day of dosing) to Day 21 post study drug injection.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Drug: 99mTc-MIP-1404</title>
          <description>20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404&#xD;
Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director, Clinical Science Communications</name_or_title>
      <organization>Progenics Pharmaceuticals, Inc.</organization>
      <phone>914 784-1825</phone>
      <email>vdipippo@progenics.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667536
org study id: MIP-1404-201
nct id: NCT01667536
lead sponsor: 
has dmc: No
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and
      performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic
      lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI
      were also assessed, as judged by histopathology results.
This is a single arm, open label study of approximately 100 high-risk prostate cancer
      patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients
      receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours
      after injection. As standard of care, patients will undergo prostatectomy and extended pelvic
      lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image
      data will be evaluated for visible uptake and compared with histopathology.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
description: For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.
measure: Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
description: For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.
measure: Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
description: For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.
measure: Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
description: For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined "tissue-segments") from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.
measure: Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
description: Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.
measure: Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
description: Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.
arm group label: Drug: 99mTc-MIP-1404
arm group type: Experimental
description: 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
intervention type: Drug
intervention name: Drug: 99mTc-MIP-1404
description: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
arm group label: Drug: 99mTc-MIP-1404
other name: MIP-1404
criteria: 
gender: Male
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas Scherr, M.D.
role: Principal Investigator
affiliation: New York Presbyterian Hospital-Cornell
last name: Jeffrey Karnes, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Kevin Slawin, MD
role: Principal Investigator
affiliation: University of Texas Vanguard Urologic Research Foundation
last name: Thomas Keane, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
last name: Edouard Trabulsi, MD
role: Principal Investigator
affiliation: Thomas Jefferson University / Jefferson Urology Associates
last name: David Jarrard, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: William Ellis, MD
role: Principal Investigator
affiliation: University of Washington
last name: Judd Moul, MD
role: Principal Investigator
affiliation: Duke University
last name: Eric Klein, MD
role: Principal Investigator
affiliation: Glickman Urology & Kidney Institute, Cleveland Clinic
last name: Bertram Yuh, MD
role: Principal Investigator
affiliation: City of Hope National Cancer Center
last name: Steven Joniau, MD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
last name: Alberto Briganti, MD
role: Principal Investigator
affiliation: Vita-Salute University San Raffaele
last name: Paolo Gontero, MD
role: Principal Investigator
affiliation: University of Turin, Italy
last name: Mikhail I Shkolnik, MD
role: Principal Investigator
affiliation: Federal State Public Institution Russian Research center for Radiology and Surgical Technologies under the Federal agency for High-tech medical care
last name: Petr A Karlov, MD
role: Principal Investigator
affiliation: St. Petersburg State Public Medical Institution: "Clinical Oncological Center"
last name: Vsevolod B Matveev, MD
role: Principal Investigator
affiliation: Federal Public State Institution "Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of medical sciences"
last name: Boris Ya Alexeev, MD
role: Principal Investigator
affiliation: Moscow Oncology Research Institute n.a. P.A. Hertsen
last name: Sergey V Mishugin, MD
role: Principal Investigator
affiliation: City Clinical Hospital # 57
last name: Oleg B Karyakin
role: Principal Investigator
affiliation: Federal State Public Institution "Medical Radiology Research Center" of Healthcare Ministry and Social Development of Russian Federation
last name: Alexander K Nosov, MD
role: Principal Investigator
affiliation: Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development
last name: Sergey B Petrov, MD
role: Principal Investigator
affiliation: All-Russia Centre for Urgent Care and Radiation Medicine named after A.M. Nikiforov under the Ministry of the Russian Federation for Civil Defence, Emergencies and Elimination of Consequences of Natural Disasters
last name: Milan Hora, MD, PhD
role: Principal Investigator
affiliation: University Hospital Plzen, Department of Urology
last name: Josef Stolz, MD
role: Principal Investigator
affiliation: University Hospital Motol, Clinic of Urology
last name: Vladimir Student, MD, PhD
role: Principal Investigator
affiliation: University Hospital Olomouc, Clinic of Urology
last name: Marek Krolupper, MD
role: Principal Investigator
affiliation: Hospital Na Bulovce, Department of Urology
last name: Michael Pesl,, MD
role: Principal Investigator
affiliation: General University Hospital in Prague, Clinic of Urology
last name: Roman Zachoval,, MD, PhD, MBA
role: Principal Investigator
affiliation: Thomayer's Hospital
last name: Marcin Matuszewski, MD, PhD
role: Principal Investigator
affiliation: University Clinical Centre, Department of Urology
last name: Henryk Zielinski, MD
role: Principal Investigator
affiliation: University Hospital Plzen, Department of Urology
last name: Jerzy Sokolowski, MD, PhD
role: Principal Investigator
affiliation: Provincial Specialist Hospital in Wroclaw, Department of Urology
last name: Tomasz Szydelko, MD, PhD
role: Principal Investigator
affiliation: 4th Military Teaching Hospital and Polyclinic,
last name: Geza Boszormenyi-Nagy, MD
role: Principal Investigator
affiliation: Bajcsy-Zsilinszky Hospital, Department of Urology
last name: Peter Tenke, MD
role: Principal Investigator
affiliation: Jahn Ferenc South Pest Hospital, Department of Urology
last name: Istvan Buzogany, MD
role: Principal Investigator
affiliation: Peterfy Sandor Street Hospital, Department of Urology
last name: Michiel Sedelaar, MD
role: Principal Investigator
affiliation: UMC St. Radboud Nijmegen
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country: Belgium
country: Czech Republic
country: Hungary
country: Italy
country: Netherlands
country: Poland
country: Russian Federation
country: United States
country: Germany
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citation: Godoy G, Chong KT, Cronin A, Vickers A, Laudone V, Touijer K, Guillonneau B, Eastham JA, Scardino PT, Coleman JA. Extent of pelvic lymph node dissection and the impact of standard template dissection on nomogram prediction of lymph node involvement. Eur Urol. 2011 Aug;60(2):195-201. doi: 10.1016/j.eururo.2011.01.016. Epub 2011 Jan 18.
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PMID: 12520562
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 