Suspended • Phase I • Stage I, II, III • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
68-Ga-RM2 PET/MRI in Imaging 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.
I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases
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.
Actual study start date:
March 19, 2019
Ages eligible for study:
18 - 999
Sexes eligible for study:
Arms and Intervention
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
Magnetic Resonance Imaging
Positron Emission Tomography
Investigational software and coils in PET/MR scan
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)
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