Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma
Status: Recruiting
Location: See location...
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
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.