Anti-1-amino-3-[18F]Fluorocyclobutyl-1-carboxylic Acid (Anti-[18F](FACBC)Positron Emission Tomography (PET-CT) of the Breast
Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010 leading to 39,840 cancer related deaths.
Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become the a standard method for isolating the tumor. However, FDG is insensitive in small breast tumors and certain histologic types such as lobular, certain types of breast carcinoma. In addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging tool that increases the ability to characterize detect breast carcinoma and to detect locoregional spread, as well as monitor therapeutic treatment response.
anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments,FACBC has shown uptake in the breast tumor cell line.
The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics via time-activity curves from dynamic imaging characteristics. The investigators will enroll 12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The investigators will then compare findings to determine if this radiotracer is worthy of further study in a more comprehensive experiment.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Amino Acid Transport Imaging of Breast Carcinoma Via Anti-3-[18F]FACBC PET-CT: A Pilot Study|
- Presence of FACBC radiotracer in breast carcinoma on FACBC PET scan [ Time Frame: Outcomes will be assessed at the end of one year. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Drug FACBC will be given intravenously (IV) over 2 minutes prior to performing the PET scan
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659645
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Leah Bellamy, RN 404-712-7965 email@example.com|
|Contact: David Schuster, MD 404-712-4859 firstname.lastname@example.org|
|Sub-Investigator: Mary Newell, MD|
|Sub-Investigator: Michael Cohen, MD|
|Sub-Investigator: Toncred Styblo, MD|
|Sub-Investigator: Ruth O'Reagan, MD|