PSMA PET for Liver Cancer Staging and Management
This study is looking at how a special type of scan, called F18-Piflufolastat (PSMA) PET/CT, can help doctors better understand and manage hepatocellular carcinoma (HCC), which is the most common type of liver cancer. Researchers want to see if adding this scan to regular imaging (like CT or MRI) can improve how doctors diagnose unclear spots on the liver, accurately stage the cancer in people who haven't started treatment, and check how well treatments are working. The goal is to see if PSMA PET/CT can help doctors make better decisions about your care at different stages of HCC. This is an observational study, meaning you would receive the scan in addition to your usual care, and doctors would observe the results. About 90 people are planned to join. To be eligible, you must be an adult (over 18) from the VA medical system with HCC that is BCLC B or C, and you cannot have certain kidney problems, contrast allergies, or other active cancers.
- Study design
- This is an observational study involving about 90 participants. It is a single-center study, meaning it takes place at one location.
- What's involved
- Participants will undergo PSMA PET/CT imaging in addition to their standard-of-care imaging (CT and/or MRI). The study does not specify the number of visits or the total duration of participation.
- Compensation
- Not stated in the trial record.
- Follow-up
- Assessments related to the study's goals will be measured within 30 days of PET/CT imaging or post-treatment imaging.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PSMA PET for the Staging and Management of Hepatocellular Carcinoma
At a glance
Conditions
NCT07019844
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Miami VA Healthcare System, Miami, FL
Miami, Floridastudy coordinator listed
Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Binu V John, MD MPH · PRINCIPAL_INVESTIGATOR · Miami VA Healthcare System, Miami, FL
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- 1: Change in Diagnostic Classification of Indeterminate Lesions (LI-RADS 3/4) After PSMA PET/CT; 2: Change in Clinical Staging in Treatment-Naïve Patients; 3: Change in Assessment of Treatment Response Following Locoregional Therapy1: Within 30 days of PET/CT imaging; 2: Within 30 days of PET/CT imaging; 3: Within 30 days of post-treatment imaging
1. Proportion of patients with LI-RADS 3/4 lesions whose diagnostic classification is revised (i.e., confirmed as HCC or benign) based on F18-Piflufolastat PET/CT findings, as compared to standard imaging alone. Final diagnosis will be based on histopathology (if available) or multidisciplinary tumor board consensus; 2. Number and percentage of treatment-naïve patients whose disease stage is upstaged or down-staged after PSMA PET/CT imaging, relative to standard imaging, according to modified BCLC or AJCC staging guidelines; 3. Difference in tumor viability classification based on PSMA PET/CT vs. standard imaging using mRECIST or LI-RADS treatment response criteria. Correlation with histopathologic or clinical follow-up will be evaluated where available.