An Investigational Scan (Fluorine F 18 Fluorocholine PET/CT) as a Predictor of Response to Immunotherapy in Patients with Liver Carcinoma

Inclusion Criteria

• Age 18 years or older (no upper limit of age)
• Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network (NCCN) guidelines (3.2019 version or higher)
• Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and/or locoregional therapy
• Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 on CT/MRI completed within past 6 weeks of eligibility screening
• Under the care of a licensed medical oncologist
• Life expectancy > 6 months
• Deemed eligible for treatment with an immune checkpoint inhibitor agent based on the treating medical oncologist's assessment of previous treatment failure, clinical/performance/virology status, and liver/renal/hematologic function
• Child-Pugh score of 9 or less
• Measured or calculated creatinine clearance >= 40 mL/min using the Cockcroft-Gault formula
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 7 x upper limit of normal
• Total bilirubin =< 4 mg/dL
• Albumin >= 2.8 g/dL

Exclusion Criteria

• Weight > 500 pounds (lbs) (PET/CT limit)
• Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET/CT imaging)
• Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
• Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an immune checkpoint inhibitor (ICI)-treatment trial and combination ICI treatment are allowed