Recruiting
Phase 2

PET/CT

Sponsor:

Queen's Medical Center

Code:

NCT04965454

Conditions

Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluorine-18 fluorocholine

Study Details

Brief summary:

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Study ID

NCT04965454

Start date

Mar 28, 2022

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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) v1.1 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
  • Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula
  • ALT and AST ≤7x upper limit of normal
  • Total bilirubin ≤4 mg/dL
  • Albumin ≥2.8 g/dL

Exclusion Criteria:

  • Weight > 500 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 ICI-treatment trial and combination ICI treatment are allowed.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Tested with Biomarkers

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.

Interventions

Fluorine-18 fluorocholine

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.

Primary outcome measure

  • Lack of Objective Response [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Abrar M Al-Adhmi, BS

808-691-7429aaadhmi@queens.org

Tim Kelleher, RN

808-691-8582tkelleher@queens.org

Locations

The Queen's Medical Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Miles Sato, MS

808-691-8584msato@queens.org

Sandi A Kwee, MD

808-691-5466skwee@queens.org

Principal Investigator:

Sandi A Kwee, MD

More Information

Sponsor

Queen's Medical Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • hepatocellular carcinoma
  • immunotherapy
  • positron emission tomography
  • mutation profiling
  • liquid biopsy
  • personalized medicine
  • diagnostic
  • fluorocholine
  • immune checkpoint inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's Medical Center on 2026-08-12.