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.
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 the concordance of tumor detection by 18F-FSPG PET/CT imaging and SOC imaging. 4. To establish whether 18F-FSPG uptake and levels of ctDNA can be utilized as imaging and bloodbased markers, respectively, to inform the response to therapy or lack thereof earlier than SOC imaging. 5. To evaluate the relationship between 18F-FSPG PET, ctDNA, and SOC imaging to TTP or PFS. 6. To evaluate voxel-wise relationships between 18F-FSPG intra-tumoral accumulation and SOC imaging. 7. To evaluate the treatment response using the mRECIST and LI-RADS criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Given by injection
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSafety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
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