<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/NCT03809078</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-48151</org_study_id>
    <secondary_id>PROS0091</secondary_id>
    <secondary_id>IRB-48151</secondary_id>
    <secondary_id>NCI-2019-00236</secondary_id>
    <nct_id>NCT03809078</nct_id>
  </id_info>
  <brief_title>A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer</brief_title>
  <official_title>A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrei Iagaru</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Electric</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for&#xD;
      biopsy guidance in patients with suspected prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance&#xD;
      in patients with suspected prostate cancer.&#xD;
&#xD;
      Exploratory Objective:&#xD;
&#xD;
        -  Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy&#xD;
&#xD;
        -  Correlation of 68Ga RM2 and Gleason score at biopsy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Business decision - funding&#xD;
  </why_stopped>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PET based Biopsy Guidance</measure>
    <time_frame>12 months</time_frame>
    <description>PET based Biopsy Guidance will be assessed as number of participants with biopsy results correlated with imaging findings (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). The outcome will be reported as the number of participants without dispersion for which PET based biopsy guidance is successfully obtained.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>68Ga RM2 first followed by 68Ga PSMA11</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11</description>
  </arm_group>
  <arm_group>
    <arm_group_label>68Ga PSMA11 first followed by 68Ga RM2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga RM2</intervention_name>
    <description>PET radiopharmaceutical</description>
    <arm_group_label>68Ga PSMA11 first followed by 68Ga RM2</arm_group_label>
    <arm_group_label>68Ga RM2 first followed by 68Ga PSMA11</arm_group_label>
    <other_name>68Ga DOTA Bombesin</other_name>
    <other_name>BAY86 7548</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-PSMA-11</intervention_name>
    <description>PET radiopharmaceutical</description>
    <arm_group_label>68Ga PSMA11 first followed by 68Ga RM2</arm_group_label>
    <arm_group_label>68Ga RM2 first followed by 68Ga PSMA11</arm_group_label>
    <other_name>DFKZ 11</other_name>
    <other_name>HBED CC PSMA</other_name>
    <other_name>Heidelberg compound</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational PET scanner coils and software</intervention_name>
    <description>GE Healthcare non-approved PET scanner coils and software</description>
    <arm_group_label>68Ga PSMA11 first followed by 68Ga RM2</arm_group_label>
    <arm_group_label>68Ga RM2 first followed by 68Ga PSMA11</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected prostate cancer&#xD;
&#xD;
          -  Planned prostate biopsy&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
          -  Karnofsky performance status of 50 (or ECOG/WHO equivalent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not capable of getting PET study due to weight, claustrophobia, or inability&#xD;
             to lay still for the duration of the exam&#xD;
&#xD;
          -  Metallic implants (contraindicated for MRI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrei H Iagaru, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Andrei Iagaru</investigator_full_name>
    <investigator_title>Associate Professor of Radiology (Nuclear Medicine)</investigator_title>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
    <mesh_term>Bombesin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03809078
org study id: IRB-48151
secondary id: PROS0091
secondary id: IRB-48151
secondary id: NCI-2019-00236
nct id: NCT03809078
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for
      biopsy guidance in patients with suspected prostate cancer.
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance
      in patients with suspected prostate cancer.

      Exploratory Objective:

        -  Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy

        -  Correlation of 68Ga RM2 and Gleason score at biopsy
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: PET based Biopsy Guidance
time frame: 12 months
description: PET based Biopsy Guidance will be assessed as number of participants with biopsy results correlated with imaging findings (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). The outcome will be reported as the number of participants without dispersion for which PET based biopsy guidance is successfully obtained.
arm group label: 68Ga RM2 first followed by 68Ga PSMA11
arm group type: Experimental
description: Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
arm group label: 68Ga PSMA11 first followed by 68Ga RM2
arm group type: Experimental
description: Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
intervention type: Drug
intervention name: 68Ga RM2
description: PET radiopharmaceutical
arm group label: 68Ga PSMA11 first followed by 68Ga RM2
arm group label: 68Ga RM2 first followed by 68Ga PSMA11
other name: 68Ga DOTA Bombesin
other name: BAY86 7548
intervention type: Drug
intervention name: 68Ga-PSMA-11
description: PET radiopharmaceutical
arm group label: 68Ga PSMA11 first followed by 68Ga RM2
arm group label: 68Ga RM2 first followed by 68Ga PSMA11
other name: DFKZ 11
other name: HBED CC PSMA
other name: Heidelberg compound
intervention type: Device
intervention name: Investigational PET scanner coils and software
description: GE Healthcare non-approved PET scanner coils and software
arm group label: 68Ga PSMA11 first followed by 68Ga RM2
arm group label: 68Ga RM2 first followed by 68Ga PSMA11
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrei H Iagaru, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Stanford University
investigator full name: Andrei Iagaru
investigator title: Associate Professor of Radiology (Nuclear Medicine)
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
mesh term: Bombesin
sharing ipd: No