NCT07019844 PSMA PET for the Staging and Management of Hepatocellular Carcinoma
| NCT ID | NCT07019844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2024-09-19 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Binu V John, MD MPH
PRINCIPAL INVESTIGATOR
Miami VA Healthcare System, Miami, FL
Frequently Asked Questions
Who can join the NCT07019844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07019844 currently recruiting?
Yes, NCT07019844 is actively recruiting participants. Contact the research team at binu.john@va.gov for enrollment information.
Where is the NCT07019844 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07019844 clinical trial?
NCT07019844 is sponsored by VA Office of Research and Development. The principal investigator is Binu V John, MD MPH at Miami VA Healthcare System, Miami, FL. The trial plans to enroll 90 participants.
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