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

Phase 1

Completed

• Conditions: Estrogen Receptor Positive; Breast Carcinoma
• 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

• Registration Number: NCT03831711
• Lead Sponsor: Andrei Iagaru

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 Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Study Start: 2019-03-19
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2023-11
• Results First Submitted: 2023-11-20
• Results First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Results First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (68-Ga RM2, PET/MRI)	Gallium Ga 68-labeled GRPR Antagonist BAY86-7548	Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Diagnostic (68-Ga RM2, PET/MRI)	Positron Emission Tomography	Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Diagnostic (68-Ga RM2, PET/MRI)	Investigational software and coils in PET/MR scan	Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Diagnostic (68-Ga RM2, PET/MRI)	Magnetic Resonance Imaging	Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.

Primary Outcome Measures

Name	Time	Method
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI	up to 2 hours	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.

Trial Locations

Locations (1)

Stanford Cancer Institute Palo Alto; 🇺🇸 Palo Alto, California, United States