PSMA PET for the Staging and Management of Hepatocellular Carcinoma

Part of paid clinical trials in Miami, Florida.

Sponsor
VA Office of Research and Development
Study ID
NCT07019844
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 19, 2024
Status verified
Jul 2025
Primary completion
Dec 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Miami VA Healthcare System, Miami, FLMiamiFlorida33125
Binu V John, MD MPH
[email protected]
305-575-7000
Flavia R Carneiro, PhD
[email protected]
(305) 575-7762
Binu V John, MD MPH (PRINCIPAL_INVESTIGATOR)

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By research site
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