PSMA PET/CT for staging and managing hepatocellular carcinoma
Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma
PSMA PET/CT will be tried alongside standard CT or MRI to see if it improves diagnosis, staging, and tracking of treatment response for adults with suspected or confirmed hepatocellular carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07019844 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center study at the Miami VA adds F18‑Piflufolastat (PSMA) PET/CT to standard-of-care cross-sectional imaging (CT and/or MRI) for patients with suspected or confirmed HCC. Participants include VA patients over age 18 and encompass scenarios of indeterminate liver lesions (LI-RADS 3–4), treatment‑naïve staging, and assessment after locoregional therapy. The study compares diagnostic accuracy, detection of intrahepatic and extrahepatic disease, and imaging-based treatment response with and without PSMA PET/CT, and documents any resulting changes in clinical management. Imaging findings will be correlated with conventional imaging and clinical follow-up to determine added clinical utility.
Who should consider this trial
Good fit: Ideal candidates are adult VA patients with suspected or confirmed hepatocellular carcinoma, including treatment‑naïve patients with BCLC B or C disease, those with indeterminate LI-RADS 3–4 lesions, or patients undergoing locoregional therapy who need response assessment.
Not a fit: Patients who cannot receive contrast-enhanced cross-sectional imaging due to renal dysfunction or contrast allergy, those with an active non‑HCC primary malignancy within the past three years, or patients unable to attend the Miami VA site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, PSMA PET/CT could detect additional intrahepatic or extrahepatic disease and improve staging accuracy, leading to more informed treatment decisions and potentially better outcomes.
How similar studies have performed: Small prior studies have reported PSMA uptake in HCC and promising lesion detection, but the approach is still relatively novel and not yet widely validated for routine use.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- Miami VA Healthcare System, Miami, FL — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Binu V John, MD MPH — Miami VA Healthcare System, Miami, FL
- Study coordinator: Binu V John, MD MPH
- Email: binu.john@va.gov
- Phone: (305) 575-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.