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

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.

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)