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68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer

Sponsor
Andrei Iagaru (Other)
Overall Status
Suspended
CT.gov ID
NCT03831711
Collaborator
General Electric (Industry)
20
Enrollment
1
Location
1
Arm
63
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
  • Device: Investigational software and coils in PET/MR scan
 Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
Actual Study Start Date :
Mar 19, 2019
Anticipated Primary Completion Date :
Jun 18, 2023
Anticipated Study Completion Date :
Jun 18, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (68-Ga RM2, PET/MRI)

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

Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
Given IV
Other Names:
  • (68)-Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2
  • 68-Ga-Bombesin Antagonist BAY86-7548
  • 68-Ga-DOTA RM2
  • 68-Ga-DOTA-Bombesin Analog BAY86-7548
  • [68-Ga]-labeled Bombesin Analog BAY86-7548
  • [68-Ga]RM2
  • BAY 86-7548
  • Ga-68-labeled Bombesin Antagonist BAY 86-7548
  • Gallium Ga-68-labeled GRPR Antagonist RM2

    • Procedure: Magnetic Resonance Imaging
    Undergo PET/MRI
    Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

    • Procedure: Positron Emission Tomography
    Undergo PET/MRI
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

    • Device: Investigational software and coils in PET/MR scan
    General Electric (GE) Healthcare non-approved PET scanner coils and software

    Outcome Measures

    Primary Outcome Measures

    1. Detection of ER positive breast cancer and metastases on 68-Ga RM2 PET/MRI [24 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy).

    • Able to provide written consent

    • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent)

    Exclusion Criteria:

    • Less than 18 years-old at the time of radiotracer administration

    • Inability to lie still for the entire imaging time

    • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

    • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

    • Renal function impairment preventing administration of MRI contrast

    • Metallic implants (contraindicated for MRI)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304

    Sponsors and Collaborators

    • Andrei Iagaru
    • General Electric

    Investigators

    • Principal Investigator: Andrei Iagaru, Stanford Cancer Institute Palo Alto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03831711
    Other Study ID Numbers:
    • IRB-48150
    • NCI-2019-00237
    • BRS0098
    • IRB-48150
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Gastrin-Releasing Peptide
    Bombesin

    Study Results

    No Results Posted as of Dec 13, 2021