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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Carcinoma, Estrogen Receptor Positive

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (68-Ga RM2, PET/MRI)<br>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<br>* Given IV<br>* Other names: Gallium Ga-68-labeled GRPR Antagonist RM2;Procedure: Magnetic Resonance Imaging<br>* Undergo PET/MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Positron Emission Tomography<br>* Undergo PET/MRI<br>* Other names: proton magnetic resonance spectroscopic imaging;Device: Investigational software and coils in PET/MR scan<br>* General Electric (GE) Healthcare non-approved PET scanner coils and software<br>|

What is the study measuring?
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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 |