Completed • Phasen I • Stufe I, II, III • Post-Menopausal • Interventionell

Folgendes wird aus ClinicalTrials.gov importiert:

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

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.

Beschreibung

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.

Studiendesign

Zulassungskriterien

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

Einschlusskriterien

• 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)

Ausschlusskriterien

• 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)