Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY
This prospective, single-center study evaluates the clinical utility of F18-Piflufolastat (PSMA) PET/CT when added to conventional cross-sectional imaging for patients with suspected or confirmed hepatocellular carcinoma (HCC). The study aims to determine whether PSMA PET/CT improves diagnostic accuracy for indeterminate liver lesions (LI-RADS 3 and 4), enhances staging precision in treatment-naïve patients, and provides more accurate assessment of treatment response in patients undergoing locoregional therapy (LRT). The goal is to assess how PSMA PET/CT may impact clinical decision-making, staging, and management of HCC across multiple stages of disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients age \>18 years from the VA medical system
• Treatment-naïve patients with HCC with BCLC B or C disease
Locations
United States
California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITING
West Los Angeles
Florida
Miami VA Healthcare System, Miami, FL
RECRUITING
Miami
Contact Information
Primary
Binu V John, MD MPH
binu.john@va.gov
(305) 575-7000
Backup
Flavia R Carneiro, PhD
flavia.carneiro@va.gov
(305) 575-7762
Time Frame
Start Date:2024-09-19
Estimated Completion Date:2028-09-30
Participants
Target number of participants:90
Treatments
Indeterminate Lesions Cohort (Diagnosis Focus)
Participants in this cohort have liver lesions categorized as LI-RADS 3 or 4 based on standard imaging. The purpose of the PSMA PET/CT is to assist in the further characterization of these indeterminate nodules and support diagnosis of HCC or benign pathology.
Treatment-Naïve Cohort (Staging Focus)
This cohort includes participants with newly diagnosed HCC who have not yet received any locoregional or systemic therapy. PSMA PET/CT is performed to evaluate the extent of disease and detect potential intrahepatic or extrahepatic spread, contributing to improved staging accuracy.
Post-Treatment Cohort (Treatment Response Focus)
Participants in this cohort have previously undergone locoregional therapy (e.g., TACE, RFA, or ablation). PSMA PET/CT is used to assess residual or recurrent disease and help evaluate treatment response compared to standard imaging.