NCT03831711

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Carcinoma
• Estrogen Receptor Positive

Interventions

Type	Name	Description
DRUG	Gallium Ga 68-labeled GRPR Antagonist BAY86-7548	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/MRI
DEVICE	Investigational software and coils in PET/MR scan	General Electric (GE) Healthcare non-approved PET scanner coils and software

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2019-02-06
• Last updated: 2023-12-13
• Results posted: 2023-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study