Name of Clinical Trial: Fluciclovine F18 (Fluciclovine) and gallium Ga 68 (PSMA-11) PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer / NCT04750473

Summary: This is a phase I trial to evaluate how well two different drugs, Fluciclovine and PSMA, work with positron emission tomography (PET)/computed tomography (CT) in helping doctors understand and classify invasive lobular breast cancer (ILC) in patients with ILC that is suspicious for or has metastasized (spread) to other parts of the body. On one day participants will receive PSMA and a PET/CT, and on a second day they will receive Fluciclovine and a PET/CT. Information learned from this study may help researchers learn how to better identify metastatic disease in patients with ILC including how much cancer is within the body and whether and where it may have spread. This will impact appropriate staging of the cancer. This study is recruiting 20 participants.

Eligible patients: Biopsy proven ILC patients who have not received any systemic treatment with either:

a) clinical or imaging suspicion of metastatic disease, or
b) Proven metastatic disease but in whom there is suspicion of an even greater tumor burden which could change therapy approach.

Patients must be able and willing to undergo biopsy if needed per standard of care for possible metastasis, which could change therapy approach. Patients must be willing to travel to Atlanta, Georgia. THIS TRIAL HAS COMPLETED ENROLLMENT.

Why is this study Important: Information learned from this study may help researchers learn how to better identify metastatic disease in invasive lobular breast cancer patients which will impact appropriate staging.

Background: ILC accounts for approximately 15% of breast malignancies. The distinct histology and growth pattern of ILC makes it difficult to visualize with current imaging modalities such as mammography, ultrasound, FDG PET-CT, breast and whole-body MRI. The current standard of care imaging techniques for ILC are sub-optimal and there is an unmet public health need for the staging of ILC, specifically in the detection of metastatic disease.

Clinical Trial Location(s): Emory University/Winship Glenn Family Breast Cancer Program, Atlanta, Georgia or any Emory University location in the Atlanta Metro area.

Principal Investigator: David M. Schuster, MD., Dir. Division of Nuclear Medicine and Molecular Imaging, Emory University Hospital, Atlanta Georgia, USA 30322

Contact:  NOTE: THIS TRIAL HAS COMPLETED ENROLLMENT. Bridget M. Fielder at 404-778-5625 or bfielde@emory.edu

More Information: https://clinicaltrials.gov/ct2/show/NCT04750473

The Lobular Breast Cancer Alliance (LBCA) shares information about ongoing clinical trials for lobular breast cancer. LBCA does not sponsor or run the clinical trials, and the scientific validity and safety of the trials is the responsibility of the trial investigators. Learn more by directly contacting the clinical trial coordinators listed.

Patients should always discuss their participation in any clinical trial directly with their doctor. Questions to Ask your Doctor may help. Learn more about participating in clinical trials.  Learn about other lobular breast cancer clinical trials and studies.