PSMA PET for the Staging and Management of Hepatocellular Carcinoma

NCT07019844 | Recruiting

• 3 other identifiers: ONCC-006-23S1I01CX002654-01A11761959
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Adult patients age \>18 years from the VA medical system
• Treatment-naïve patients with HCC with BCLC B or C disease

You may not qualify if:

• Patients with renal dysfunction or contrast allergy that precludes contrast enhanced cross sectional imaging
• Patients with presence of active primary malignancy other than HCC and non-melanoma skin cancer in the past 3 years

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Miami VA Healthcare System: collaborator

Study Sites (1)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32128966 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Binu V John, MD MPH

  Miami VA Healthcare System, Miami, FL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binu V John, MD MPH

CONTACT

(305) 575-7000; binu.john@va.gov

Flavia R Carneiro, PhD

CONTACT

(305) 575-7762; flavia.carneiro@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: September 19, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)