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NCT Number: NCT07019844

PSMA PET for the Staging and Management of Hepatocellular Carcinoma

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States

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About this study

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and a leading cause of cancer-related mortality worldwide. Accurate diagnosis, staging, and treatment response assessment are critical for optimal management of patients with HCC. However, conventional imaging modalities, such as contrast-enhanced CT and MRI, have limitations in characterizing indeterminate liver lesions and in detecting intrahepatic or extrahepatic disease, particularly in the context of post-treatment changes.

This prospective, single-center study investigates the added value of F18-Piflufolastat (PSMA) PET/CT in the evaluation and management of patients with suspected or confirmed HCC. PSMA (Prostate-Specific Membrane Antigen) is a cell surface protein that, while originally characterized in prostate cancer, has demonstrated overexpression in the neovasculature of a variety of solid tumors, including HCC. F18-Piflufolastat is a radiotracer that targets PSMA, allowing for enhanced molecular imaging.

Participants will undergo PSMA PET/CT imaging in addition to standard-of-care imaging (CT and/or MRI). The study is designed to address three primary clinical questions:

  • Diagnosis: Does the addition of PSMA PET/CT improve characterization of indeterminate liver lesions (e.g., LI-RADS 3 or 4)?
  • Staging: Can PSMA PET/CT improve the accuracy of disease staging in treatment-naïve patients by detecting intrahepatic or extrahepatic disease not visualized on conventional imaging?
  • Treatment Response: In patients who have undergone locoregional therapy (LRT), does PSMA PET/CT provide more precise assessment of viable tumor tissue compared to standard imaging? Data collected will include imaging results, histopathological confirmation when available, changes in clinical management prompted by PSMA PET/CT findings, and correlation with clinical outcomes. By evaluating the clinical utility of PSMA PET/CT across multiple phases of the disease course, this study aims to inform future diagnostic algorithms and treatment planning strategies in patients with HCC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    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

    • 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;
    • 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;
    • 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.

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

    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

    • 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;
    • Number and percentage of treatment-naïve patients whose disease stage is upstaged or downstaged after PSMA PET/CT imaging, relative to standard imaging, according to modified BCLC or AJCC staging guidelines;
    • 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.

Other outcomes

  1. 1: Inter-reader Agreement on PSMA PET/CT Interpretation; 2: Correlation Between PSMA Uptake and Histopathologic Features

    Time frame: 1: Within 30 days of imaging; 2: Up to 90 days post-imaging (when surgical specimens are available)

    • Agreement between independent nuclear medicine readers on lesion characterization and treatment response using standardized reporting criteria (e.g., kappa statistics);
    • Quantitative PET uptake metrics (SUVmax, SUVmean) will be correlated with histologic markers of tumor grade, vascular invasion, and PSMA expression, when pathology samples are available.

Study contacts

Contact information is provided by the study sponsor or research team.

Binu V John, MD MPH

CONTACT

[email protected]

(305) 575-7000 ext. 17647

Flavia R Carneiro, PhD

CONTACT

[email protected]

(305) 575-7762

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Miami VA Healthcare System
  • VA Medical Center-West Los Angeles

Registry information

Official study title

Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 13, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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