PSMA PET/CT for staging and managing hepatocellular carcinoma
Official title: Addition of F18-Piflufolastat PET/CT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma
Run by VA Office of Research and Development · NCT07019844 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (West Los Angeles, California and 1 other locations) |
| Status | Recruiting |
| Started | September 19, 2024 |
| Main results expected | December 30, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07019844 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States Recruiting -
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.