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For this single arm study, all enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before treatment involving an immune checkpoint inhibitor agent. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake.

18F-fluorocholine is a radiopharmaceutical imaging agent intended for use only with positron emission tomography (PET) imaging. PET with in-line computed tomography imaging of the torso will be performed following intravenous administration of a single unit dose of this investigational new drug.

Fluorine-18 fluorocholine

Miles M Sato, MS, MPH

Tim Kelleher, RN

Miles Sato, MS

Sandi A Kwee, MD

Sandi A Kwee, MD, PhD

This prospective clinical trial will evaluate PET/CT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET/CT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.

This is a prospective open-label single-arm diagnostic clinical trial evaluating fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling (also referred to as genomic liquid biopsy) as diagnostic tools for predicting therapeutic response in advanced HCC patients receiving immune-checkpoint inhibitor (ICI) therapy. All enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before ICI treatment. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. The accuracy of tumor biomarkers based on PET/CT and liquid biopsy for predicting therapeutic outcome and disease progression will be determined using objective clinical endpoints based on the radiographic classification of treatment response by RECIST v1.1 applied to CT or MRI performed after 16 weeks of treatment.

prospective open-label single-arm diagnostic clinical trial

Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma

Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

Limited de-identified genomic and phenotypic individual participant data will be made available after the end of the trial via the NIH database of genotypes and phenotypes (dbGaP) in accordance with the NIH Genomic Data Sharing Policy. The individual level data made available by dbGaP is safeguarded by a process of controlled-access with data use limitations to be determined.

Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1

Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1

Disease Control defined after 16 weeks as meeting criteria for either Partial Response, Complete Response, or Stable Disease based on RECIST v1.1

National Cancer Institute (NCI)

Queen's Medical Center

Program Director, PET Research

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma	NCT04965454	Hepatocellular ...	Fluorine-18 flu...	18 Years -	Queen's Medical Center
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma	NCT04965454	Hepatocellular ...	Fluorine-18 flu...	18 Years -	Queen's Medical Center

Spots Global Cancer Trial Database for mutation profiling