Phase 1, Single-site, Single-arm, Clinical Imaging, and Blood-based Biomarker Trial Utilizing 18F-FSPG PET to Guide Therapy in Hepatocellular Carcinoma
M.D. Anderson Cancer Center
Summary
To evaluate the relationship between 18F-FSPG uptake in HCC lesions, ctDNA in blood and clinical response to Y90 radioembolization therapy in patients with hepatocellular carcinoma (HCC) by SOC imaging.
Description
Primary Objectives: 1. To establish whether pre-treatment 18F-FSPG can be utilized as an imaging marker to predict response/resistance to Y90 treatment, 2. To determine whether there is a correlation between change in 18F-FSPG uptake in HCC lesions and change in levels of ctDNA in the blood prior to and post-Y90 radioembolization and response to treatment as assessed by SOC imaging at 3-, 6-, 9-, and 12-months following the procedure. Secondary Objectives: 1. To determine if 18F-FSPG PET can visualize residual disease, 2. To determine if ctDNA can detect residual disease, 3. To determine th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of HCC with one or more of the following: 1. Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following: 1. 10-19 mm with ≥ 2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth), 2. 10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth, 3. 10-19 mm with ≥50% size increase in ≤6 months but with no "washout" or "capsule" or 4. ≥20 mm with ≥1 additional major feature according to LI-RADS c…
Interventions
- Diagnostic TestRadiopharmaceutical 18F-FSPG
Given by injection
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas