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

NCT03831711 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 3 other identifiers: IRB-48150NCI-2019-00237BRS0098
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Estrogen Receptor Positive

Outcome Measures

Primary Outcomes (1)

• Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI

  Number of lesions 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.

  up to 2 hours

Study Arms (1)

Diagnostic (68-Ga RM2, PET/MRI)

EXPERIMENTAL

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; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Device: Investigational software and coils in PET/MR scan

Interventions

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 DRUG

Given IV

Also known as: (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

Diagnostic (68-Ga RM2, PET/MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (68-Ga RM2, PET/MRI)

Positron Emission Tomography PROCEDURE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (68-Ga RM2, PET/MRI)

Investigational software and coils in PET/MR scan DEVICE

General Electric (GE) Healthcare non-approved PET scanner coils and software

Diagnostic (68-Ga RM2, PET/MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Andrei Iagaru: lead
• General Electric: collaborator

Study Sites (1)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BAY 86-7548; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Early termination led to a small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Andrei Iagaru, MD
• Organization: Stanford University

aiagaru@stanford.edu

650-725-4711

Study Officials

• Andrei Iagaru

  Stanford Cancer Institute Palo Alto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: March 19, 2019
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)