NCT07019844|Recruiting
PSMA PET for the Staging and Management of Hepatocellular Carcinoma
Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma
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Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma
Sponsor study identifier
Secondary identifiers
OTHER · VA Central Institutional Review Board Panel
observational
90
1 country
2
Study Start
September 19, 2024
Actual (reported)Primary Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 19, 2024
Actual (reported)June 5, 2025
Actual (reported)June 13, 2025
Actual (reported)December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
1: Change in Diagnostic Classification of Indeterminate Lesions (LI-RADS 3/4) After PSMA PET/CT; 2: Change in Clinical Staging in Treatment-Naïve Patients; 3: Change in Assessment of Treatment Response Following Locoregional Therapy
1. Proportion of patients with LI-RADS 3/4 lesions whose diagnostic classification is revised (i.e., confirmed as HCC or benign) based on F18-Piflufolastat PET/CT findings, as compared to standard imaging alone. Final diagnosis will be based on histopathology (if available) or multidisciplinary tumor board consensus; 2. Number and percentage of treatment-naïve patients whose disease stage is upstaged or down-staged after PSMA PET/CT imaging, relative to standard imaging, according to modified BCLC or AJCC staging guidelines; 3. Difference in tumor viability classification based on PSMA PET/CT vs. standard imaging using mRECIST or LI-RADS treatment response criteria. Correlation with histopathologic or clinical follow-up will be evaluated where available.
1: Within 30 days of PET/CT imaging; 2: Within 30 days of PET/CT imaging; 3: Within 30 days of post-treatment imaging
1: Change in Clinical Management Based on PSMA PET/CT Findings; 2: Change in Clinical Staging in Treatment-Naïve Patients; 3: Change in Assessment of Treatment Response Following Locoregional Therapy
1: Within 30 days of PET/CT imaging; 2: Within 30 days of PET/CT imaging; 3: Within 30 days of post-treatment imaging
1: Inter-reader Agreement on PSMA PET/CT Interpretation; 2: Correlation Between PSMA Uptake and Histopathologic Features
1: Within 30 days of imaging; 2: Up to 90 days post-imaging (when surgical specimens are available)
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.
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.
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.
This study will recruit 90 Veterans from the VHA with HCC, and no non-Veteran participants. This will include 30 participants with LR-3 and 4 lesions detected during surveillance (Aim 1), 30 treatment naïve participants towards Aim 2, and 30 treatment experienced participants for Aim 3. In addition, 10 participants out of the 60 who are recruited for aims 2 and 3 are projected to have indeterminate nodules, increasing the number of participants with indeterminate nodules to 40. West Palm Beach and Orlando VA patients who are evaluated at the Miami VA, will be approached for study recruitment. These Veterans will continue to be co-managed by the Miami VA and the local VA teams after undergoing treatment in Miami.
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003, United States
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125, United States
John BV, Aubuchon S, Dahman B, Konjeti VR, Heuman D, Hubert J, Thomas S, Deng Y, Solomon C, Sundaram LT, Love E, Singal AG, Tatum JL. Addition of [18 F]Fluorodeoxyglucose Positron Emission Tomography With Computed Tomography to Cross-Sectional Imaging Improves Staging and Alters Management in Hepatocellular Carcinoma. Liver Transpl. 2020 Jun;26(6):774-784. doi: 10.1002/lt.25743. Epub 2020 May 8.
Binu V John, MD MPH
Miami VA Healthcare System, Miami, FL
First Submitted
June 5, 2025
First Posted
June 13, 2025
Study Start
September 19, 2024
Actual (reported)Primary Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
Contact the study team to confirm eligibility.
Study Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 26, 2026
Record last verified: 2026-06
The United States Department of Veterans Affairs (VA) places legal restrictions on access to Veterans' healthcare data, including identifying and sensitive patient information. The analytic datasets used in this study were not permitted to leave the VA firewall without data-use agreement. This limitation is consistent with those of other studies based on VA data. However, VA data are freely available to researchers behind the VA firewall with an approved VA study protocol. For more information, please visit https://www.virec.research.va.gov or contact the VA Information Resource Center (VIReC) at Virec@Va.gov.
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Source: ClinicalTrials.gov.
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