PSMA PET for the Staging and Management of Hepatocellular Carcinoma
ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adult patients age >18 years from the VA medical system
Treatment-naïve patients with HCC with BCLC B or C disease
Disqualifiers
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
Trial population
This study will recruit 90 Veterans from the VHA with HCC, and no non-Veteran participants. This will include 30 participants with LR-3 and 4 lesions detected during surveillance (Aim 1), 30 treatment naïve participants towards Aim 2, and 30 treatment experienced participants for Aim 3. In addition, 10 participants out of the 60 who are recruited for aims 2 and 3 are projected to have indeterminate nodules, increasing the number of participants with indeterminate nodules to 40. West Palm Beach and Orlando VA patients who are evaluated at the Miami VA, will be approached for study recruitment. These Veterans will continue to be co-managed by the Miami VA and the local VA teams after undergoing treatment in Miami.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 3 trial groupsGroup A: Indeterminate Lesions Cohort (Diagnosis Focus)
Group B: Treatment-Naïve Cohort (Staging Focus)
Group C: Post-Treatment Cohort (Treatment Response Focus)
Trial outcomes
Primary outcomes
1
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 Therapy
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.
Time frame
1: Within 30 days of PET/CT imaging; 2: Within 30 days of PET/CT imaging; 3: Within 30 days of post-treatment imagingSecondary outcomes
1
1: Change in Clinical Management Based on PSMA PET/CT Findings; 2: Change in Clinical Staging in Treatment-Naïve Patients; 3: Change in Assessment of Treatment Response Following Locoregional Therapy
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 downstaged 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.
Time frame
1: Within 30 days of PET/CT imaging; 2: Within 30 days of PET/CT imaging; 3: Within 30 days of post-treatment imagingOther outcomes
1
1: Inter-reader Agreement on PSMA PET/CT Interpretation; 2: Correlation Between PSMA Uptake and Histopathologic Features
1. Agreement between independent nuclear medicine readers on lesion characterization and treatment response using standardized reporting criteria (e.g., kappa statistics); 2. Quantitative PET uptake metrics (SUVmax, SUVmean) will be correlated with histologic markers of tumor grade, vascular invasion, and PSMA expression, when pathology samples are available.
Time frame
1: Within 30 days of imaging; 2: Up to 90 days post-imaging (when surgical specimens are available)Sponsors and contacts
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VA Office of Research and Development
Lead sponsor
Miami VA Healthcare System
Collaborator
VA Medical Center-West Los Angeles
Collaborator
Source ClinicalTrials.gov