<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/NCT03831711</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-48150</org_study_id>
    <secondary_id>NCI-2019-00237</secondary_id>
    <secondary_id>BRS0098</secondary_id>
    <secondary_id>IRB-48150</secondary_id>
    <nct_id>NCT03831711</nct_id>
  </id_info>
  <brief_title>68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer</brief_title>
  <official_title>A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen&#xD;
      receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor&#xD;
      positive primary breast cancer and metastases&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60&#xD;
      minutes.&#xD;
&#xD;
      After completion of study, patients are followed up at 24-72 hours, and then for 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Logistics&#xD;
  </why_stopped>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Anticipated">June 18, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 18, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Detection of ER positive breast cancer and metastases on 68-Ga RM2 PET/MRI</measure>
    <time_frame>24 months</time_frame>
    <description>Number of lesions will be identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Estrogen Receptor Positive</condition>
  <arm_group>
    <arm_group_label>Diagnostic (68-Ga RM2, PET/MRI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gallium Ga 68-labeled GRPR Antagonist BAY86-7548</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Diagnostic (68-Ga RM2, PET/MRI)</arm_group_label>
    <other_name>(68)-Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2</other_name>
    <other_name>68-Ga-Bombesin Antagonist BAY86-7548</other_name>
    <other_name>68-Ga-DOTA RM2</other_name>
    <other_name>68-Ga-DOTA-Bombesin Analog BAY86-7548</other_name>
    <other_name>[68-Ga]-labeled Bombesin Analog BAY86-7548</other_name>
    <other_name>[68-Ga]RM2</other_name>
    <other_name>BAY 86-7548</other_name>
    <other_name>Ga-68-labeled Bombesin Antagonist BAY 86-7548</other_name>
    <other_name>Gallium Ga-68-labeled GRPR Antagonist RM2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Undergo PET/MRI</description>
    <arm_group_label>Diagnostic (68-Ga RM2, PET/MRI)</arm_group_label>
    <other_name>Magnetic Resonance Imaging Scan</other_name>
    <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
    <other_name>MRI</other_name>
    <other_name>MRI Scan</other_name>
    <other_name>NMR Imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>Nuclear Magnetic Resonance Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/MRI</description>
    <arm_group_label>Diagnostic (68-Ga RM2, PET/MRI)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational software and coils in PET/MR scan</intervention_name>
    <description>General Electric (GE) Healthcare non-approved PET scanner coils and software</description>
    <arm_group_label>Diagnostic (68-Ga RM2, PET/MRI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one&#xD;
             ER+ lesion based on results of biopsy).&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
          -  Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group&#xD;
             (ECOG)/World Health Organization (WHO) equivalent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years-old at the time of radiotracer administration&#xD;
&#xD;
          -  Inability to lie still for the entire imaging time&#xD;
&#xD;
          -  Inability to complete the needed investigational and standard-of-care imaging&#xD;
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)&#xD;
&#xD;
          -  Any additional medical condition, serious intercurrent illness, or other extenuating&#xD;
             circumstance that, in the opinion of the Investigator, may significantly interfere&#xD;
             with study compliance&#xD;
&#xD;
          -  Renal function impairment preventing administration of MRI contrast&#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 Iagaru</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Cancer Institute Palo Alto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Cancer Institute Palo Alto</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</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>Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrin-Releasing Peptide</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/NCT03831711
org study id: IRB-48150
secondary id: NCI-2019-00237
secondary id: BRS0098
secondary id: IRB-48150
nct id: NCT03831711
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen
      receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.
PRIMARY OBJECTIVES:

      I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor
      positive primary breast cancer and metastases

      OUTLINE:

      Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60
      minutes.

      After completion of study, patients are followed up at 24-72 hours, and then for 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Detection of ER positive breast cancer and metastases on 68-Ga RM2 PET/MRI
time frame: 24 months
description: Number of lesions will be identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.
arm group label: Diagnostic (68-Ga RM2, PET/MRI)
arm group type: Experimental
description: Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
intervention type: Drug
intervention name: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
description: Given IV
arm group label: Diagnostic (68-Ga RM2, PET/MRI)
other name: (68)-Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2
other name: 68-Ga-Bombesin Antagonist BAY86-7548
other name: 68-Ga-DOTA RM2
other name: 68-Ga-DOTA-Bombesin Analog BAY86-7548
other name: [68-Ga]-labeled Bombesin Analog BAY86-7548
other name: [68-Ga]RM2
other name: BAY 86-7548
other name: Ga-68-labeled Bombesin Antagonist BAY 86-7548
other name: Gallium Ga-68-labeled GRPR Antagonist RM2
intervention type: Procedure
intervention name: Magnetic Resonance Imaging
description: Undergo PET/MRI
arm group label: Diagnostic (68-Ga RM2, PET/MRI)
other name: Magnetic Resonance Imaging Scan
other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
other name: MRI
other name: MRI Scan
other name: NMR Imaging
other name: NMRI
other name: Nuclear Magnetic Resonance Imaging
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/MRI
arm group label: Diagnostic (68-Ga RM2, PET/MRI)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
intervention type: Device
intervention name: Investigational software and coils in PET/MR scan
description: General Electric (GE) Healthcare non-approved PET scanner coils and software
arm group label: Diagnostic (68-Ga RM2, PET/MRI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrei Iagaru
role: Principal Investigator
affiliation: Stanford Cancer Institute Palo Alto
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Stanford University
investigator full name: Andrei Iagaru
investigator title: Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center
mesh term: Breast Neoplasms
mesh term: Gastrin-Releasing Peptide
mesh term: Bombesin
sharing ipd: No