RECRUITING

PSMA PET for the Staging and Management of Hepatocellular Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-19
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07019844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. adult patients age\>18 years from the VA medical system; 2. Treatment-naïve patients with HCC with BCLC B or C disease.
  1. * 1. Patients with renal dysfunction or contrast allergy that precludes contrast enhanced cross sectional imaging; 2. Patients with presence of active primary malignancy other than HCC and non-melanoma skin cancer in the past 3 years.

Contacts and Locations

Study Contact

Binu John, MD, MPH
CONTACT
305-575-7647
flavia.carneiro@va.gov
Flavia Carneiro, PhD
CONTACT
305-575-7762
flavia.carneiro@va.gov

Principal Investigator

Binu John, MD, MPH
PRINCIPAL_INVESTIGATOR
Miami VA Healthcare System

Study Locations (Sites)

Miami VA Healthcare System
Miami, Florida, 33125
United States

Collaborators and Investigators

Sponsor: Miami VA Healthcare System

  • Binu John, MD, MPH, PRINCIPAL_INVESTIGATOR, Miami VA Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-09-19
Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma (HCC)