<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/NCT01730417</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00019124 (MIP-CA130394-01)</org_study_id>
    <secondary_id>5R44CA130394-03</secondary_id>
    <nct_id>NCT01730417</nct_id>
  </id_info>
  <brief_title>Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG</brief_title>
  <acronym>mIBG</acronym>
  <official_title>Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG-Nanodosing: the Path to Higher Sensitivity and Lower Toxicity Radiopharmaceuticals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bennett Chin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Molecular Insights Pharmaceuticals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane&#xD;
      I 123 in normal human volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane&#xD;
      I 123 in normal human volunteers. The low specific activity iobenguane I 123 has been shown&#xD;
      to be useful for the detection and staging of neuroendocrine tumors in adults and children&#xD;
      and imaging neuronal activity in the heart. The innovation in this proposal is through the&#xD;
      use of patented solid phase technology to produce a proven diagnostic agent at extremely high&#xD;
      specific activity to increase sensitivity and specificity and lower radiation exposure to&#xD;
      normal organs without the pharmacologically active cold carrier compound. The FDA considers&#xD;
      iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as two distinct&#xD;
      drugs requiring distinct regulatory applications.&#xD;
&#xD;
      To meet the required quality standards for the chemistry, manufacturing and controls&#xD;
      component of an IND application, GMP quality polymer drug precursor is used to generate the&#xD;
      Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the proposed&#xD;
      final drug formulation to demonstrate the final drug does not interfere with tests used to&#xD;
      define the identity, purity, and strength of the agent. The drug product was verified for&#xD;
      apyrogenicity and sterility before human testing. The IND application was written and&#xD;
      submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical trial material,&#xD;
      and will conduct human testing of the radioactive drug substance for safety and superiority&#xD;
      compared to conventional iobenguane I 123 in normal healthy volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <phase>Phase 1</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>Radiation dosimetry</measure>
    <time_frame>2 weeks</time_frame>
    <description>Radiation dosimetry was measured by imaging at several time points. Blood and urine samples were also collected to correlate with imaging parameters. Side effects were also assessed after drug administration.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Radiation dosimetry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no carrier added metaiodobenzylguanidine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>no carrier added metaiodobenzylguanidine</intervention_name>
    <description>Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG</description>
    <arm_group_label>Radiation dosimetry</arm_group_label>
    <other_name>Ultratrace</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  normal healthy volunteers with written informed consent who understand and are willing&#xD;
             to comply with protocol requirements&#xD;
&#xD;
          -  at least 21 years of age&#xD;
&#xD;
          -  if female, then not of childbearing potential as documented by history (e.g., tubal&#xD;
             ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses&#xD;
&#xD;
          -  if female of childbearing potential, a negative serum beta HCG pregnancy test within&#xD;
             24 hours prior to receiving iobenguane I 123&#xD;
&#xD;
          -  if female of childbearing potential, agrees to use an acceptable form of birth&#xD;
             control, defined as abstinence or use of IUD, oral contraceptive, barrier and&#xD;
             spermicide, or hormonal implant, throughout the study period&#xD;
&#xD;
          -  No existing predisposition to administration of thyroid blocking potassium iodide&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  females who are nursing&#xD;
&#xD;
          -  documented history of significant allergy that required medical intervention to&#xD;
             shellfish, X-ray contrast media, iodine/iodides, or iobenguane&#xD;
&#xD;
          -  administered a radioisotope within 5 effective half-lives of that radioisotope prior&#xD;
             to study enrollment&#xD;
&#xD;
          -  abnormal screening laboratory studies (serum creatinine, SPOT, SGPT, total bilirubin&#xD;
             as defined by standard laboratory reference ranges)&#xD;
&#xD;
          -  those who have received an investigational compound and/or medical device within 30&#xD;
             days of entering this study&#xD;
&#xD;
          -  pre-existing medical condition or circumstances which would significantly decrease the&#xD;
             chances of obtaining reliable data, achieving study objectives, or completing the&#xD;
             study, (e.g. cancer, heart disease, or other medical conditions which potentially&#xD;
             alter normal biodistribution)&#xD;
&#xD;
          -  is determined by the investigator that the patient is clinically unsuitable for the&#xD;
             study&#xD;
&#xD;
          -  are taking medication which inhibits uptake of iobenguane I 123 within 2 weeks of&#xD;
             enrollment, or tricyclic antidepressants or related drugs within 6 weeks of&#xD;
             enrollment. Categories of medications include sympathomimetics, antihypertensives and&#xD;
             cardiovascular agents, opioids, antipsychotics, tricyclic antidepressants, and&#xD;
             medications as previously published&#xD;
&#xD;
          -  have participated in a clinical trial with an investigational drug in the past 30&#xD;
             days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bennett B Chin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765-71. doi: 10.2967/jnumed.113.124057. Epub 2014 Mar 13.</citation>
    <PMID>24627436</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Bennett Chin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Phase 1</keyword>
  <keyword>no carrier added metaiodobenzylguanidine</keyword>
  <keyword>radiation dosimetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>3-Iodobenzylguanidine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01730417
org study id: Pro00019124 (MIP-CA130394-01)
secondary id: 5R44CA130394-03
nct id: NCT01730417
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane
      I 123 in normal human volunteers.
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane
      I 123 in normal human volunteers. The low specific activity iobenguane I 123 has been shown
      to be useful for the detection and staging of neuroendocrine tumors in adults and children
      and imaging neuronal activity in the heart. The innovation in this proposal is through the
      use of patented solid phase technology to produce a proven diagnostic agent at extremely high
      specific activity to increase sensitivity and specificity and lower radiation exposure to
      normal organs without the pharmacologically active cold carrier compound. The FDA considers
      iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as two distinct
      drugs requiring distinct regulatory applications.

      To meet the required quality standards for the chemistry, manufacturing and controls
      component of an IND application, GMP quality polymer drug precursor is used to generate the
      Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the proposed
      final drug formulation to demonstrate the final drug does not interfere with tests used to
      define the identity, purity, and strength of the agent. The drug product was verified for
      apyrogenicity and sterility before human testing. The IND application was written and
      submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical trial material,
      and will conduct human testing of the radioactive drug substance for safety and superiority
      compared to conventional iobenguane I 123 in normal healthy volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Radiation dosimetry
time frame: 2 weeks
description: Radiation dosimetry was measured by imaging at several time points. Blood and urine samples were also collected to correlate with imaging parameters. Side effects were also assessed after drug administration.
arm group label: Radiation dosimetry
arm group type: Experimental
description: no carrier added metaiodobenzylguanidine
intervention type: Drug
intervention name: no carrier added metaiodobenzylguanidine
description: Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG
arm group label: Radiation dosimetry
other name: Ultratrace
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bennett B Chin, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
citation: Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765-71. doi: 10.2967/jnumed.113.124057. Epub 2014 Mar 13.
PMID: 24627436
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Bennett Chin
investigator title: Principal Investigator
mesh term: Neuroendocrine Tumors
mesh term: 3-Iodobenzylguanidine