Recruiting

F18-Piflufolastat

Sponsor:

VA Office of Research and Development

Code:

NCT07019844

Conditions

Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT07019844

Start date

Sep 19, 2024

Status verified date

Jun, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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 [ Time Frame: 1: Within 30 days of PET/CT imaging; 2: Within 30 days of PET/CT imaging; 3: Within 30 days of post-treatment imaging ]

Central Contacts and Locations

Central contacts

Binu V John, MD MPH

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

Flavia R Carneiro, PhD

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

Locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Recruiting

West Los Angeles, California, United States, 90073-1003

Contacts

Anthony Bejjani, MD

(31-0) -3711anthony.bejjani@va.gov

Samantha Tran, BS

310 4783711samantha.tran@va.gov

Miami VA Healthcare System, Miami, FL

Recruiting

Miami, Florida, United States, 33125

Contacts

Binu V John, MD MPH

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

Flavia R Carneiro, PhD

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

Principal Investigator:

Binu V John, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-26.