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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831711
Recruitment Status : Suspended (Logistics)
First Posted : February 6, 2019
Last Update Posted : December 13, 2021
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date December 13, 2021
Actual Study Start Date  ICMJE March 19, 2019
Estimated Primary Completion Date June 18, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Detection of ER positive breast cancer and metastases on 68-Ga RM2 PET/MRI [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
Number of lesions identified on 68Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI) [ Time Frame: Up to 12 months ]
The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
Official Title  ICMJE A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Carcinoma
  • Estrogen Receptor Positive
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 18, 2024
Estimated Primary Completion Date June 18, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03831711
Other Study ID Numbers  ICMJE IRB-48150
NCI-2019-00237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRS0098 ( Other Identifier: OnCore )
IRB-48150 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrei Iagaru, Stanford University
Study Sponsor  ICMJE Andrei Iagaru
Collaborators  ICMJE General Electric
Investigators  ICMJE
Principal Investigator: Andrei Iagaru Stanford Cancer Institute Palo Alto
PRS Account Stanford University
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP