Clinical Trial · NCT04750473

Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer

Overview

This phase I trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) and PSMA PET/CT work in helping doctors understand and classify invasive lobular breast cancer in patients with invasive lobular breast cancer that is suspicious for or has spread to other places in the body (metastasized). Fluciclovine and PSMA are radiotracers used in PET/CT imaging scans that emit radiation. The PET/CT scan than picks up the radiation being released to create a picture from within the body. 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.

Sponsor

Emory University

Phase

Phase 1

Contacts

David M Schuster, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04750473

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Linker: Ahx

Fluciclovine

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach
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 that could change therapy approach
Treatment naive biopsy proven ILC patients with ILC

Exclusion

Pregnancy. Qualitative or quantitative serum or urine pregnancy test will be done in women of childbearing potential within 24 hours before PET