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

Andrei Iagaru

Status and phase: Completed; Phase 2; Phase 1

Conditions: Estrogen Receptor Positive; Breast Carcinoma

Treatments: Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548; Device: Investigational software and coils in PET/MR scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03831711

BRS0098 (Other Identifier)

IRB-48150 (Other Identifier)

NCI-2019-00237 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Diagnostic (68-Ga RM2, PET/MRI)

Experimental group

Description:

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

Treatment:

Device: Investigational software and coils in PET/MR scan

Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Procedure: Magnetic Resonance Imaging

Procedure: Positron Emission Tomography