PSMA PET for the Staging and Management of Hepatocellular Carcinoma

NCT ID: NCT07019844

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2028-09-30

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.

Detailed Description

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:

1. Diagnosis: Does the addition of PSMA PET/CT improve characterization of indeterminate liver lesions (e.g., LI-RADS 3 or 4)?

2. 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?

3. 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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miami VA Healthcare System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binu V John, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Miami VA Healthcare System, Miami, FL

Locations

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Binu V John, MD MPH

Role: CONTACT

binu.john@va.gov

(305) 575-7000 ext. 17647

Flavia R Carneiro, PhD

Role: CONTACT

flavia.carneiro@va.gov

(305) 575-7762

Facility Contacts

Binu V John, MD MPH

Role: primary

binu.john@va.gov

305-575-7000 ext. 17647

Flavia R Carneiro, PhD

Role: backup

flavia.carneiro@va.gov

(305) 575-7762

References

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.

Reference Type: BACKGROUND

PMID: 32128966 (View on PubMed)

Other Identifiers

1I01CX002654-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1761959

Identifier Type: OTHER

Identifier Source: secondary_id

ONCC-006-23S

Identifier Type: -

Identifier Source: org_study_id