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

A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Estrogen Receptor Positive
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Device: Investigational software and coils in PET/MR scan

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: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Institute Palo Alto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Procedure: Magnetic Resonance Imaging; Undergo PET/MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; 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; Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Given IV; Other Names: BAY 86-7548; Ga-68-labeled Bombesin Antagonist BAY 86-7548; (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; Gallium Ga-68-labeled GRPR Antagonist RM2; Device: Investigational software and coils in PET/MR scan; General Electric (GE) Healthcare non-approved PET scanner coils and software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Andrei Iagaru
• Collaborators: General Electric
• Investigators: Principal Investigator: Andrei Iagaru, Stanford Cancer Institute Palo Alto

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bombesin; Gastrin-Releasing Peptide
• Other Study ID Numbers: IRB-48150 (Other Identifier: Stanford IRB); NCI-2019-00237 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); BRS0098 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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