GE Healthcare presented results of a phase 1 study of [18F]FACBC at the annual meeting of SNM last week in Salt Lake City.
The presentation closely follows the launch of the phase 2 clinical development program for anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid ([18F]FACBC), which was initially discovered and developed by Emory University in Atlanta and was licensed to Nihon Medi-Physics (NMP) in Tokyo. [18F]FACBC is under development by GE under a sub-license from NMP, which is currently conducting a phase 1 study of the compound in Japan.
[18F]FACBC is a synthetic amino acid analogue-based PET imaging agent being developed by GE as a clinical diagnostic tool. According to the company, the goal of the phase 1 program was to test the potential utility of [18F]FACBC at delineating primary prostate tumors, lymph node metastasis and seminal vesicle involvement.
The study included six patients with primary prostate cancer who underwent up to 120 minutes of dynamic PET/CT imaging. Visual and quantitative imaging assessments were performed. Standardized uptake value analysis of malignant and normal prostate tissue was correlated with standard-of-care imaging and biopsy results.
The researchers concluded that [18F]FACBC is an effective agent for delineating primary prostate tumors and lymph node metastases.
The [18F]FACBC phase 2 clinical development program was initiated at the end of April with the launch of study IND 107707. A total of 80 patients scheduled for prostatectomy will be enrolled at multiple sites in the U.S. and Europe.