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Diagnostic Study for Inoperable Liver Cancer with PET/CT and Liquid Biopsy

This study is for people with hepatocellular carcinoma (HCC), a type of liver cancer, that cannot be removed by surgery. It's looking at how well a special imaging scan called Fluorine-18 fluorocholine (FCH) PET/CT and a blood test called a genomic liquid biopsy can predict if immune-checkpoint inhibitor (ICI) therapy will work. You would be eligible if you are 18 or older, have HCC that can't be surgically removed or has progressed after other treatments. The main goal is to see if the FCH PET/CT scan can predict if your cancer won't respond to ICI therapy after 16 weeks. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same diagnostic tests. It plans to enroll 80 participants.
What's involved
You would undergo FCH PET/CT and genomic liquid biopsy before starting ICI treatment. An additional PET/CT scan might be done before treatment and after 8 weeks if your initial FCH PET/CT shows low or uneven tumor uptake.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed after 16 weeks using CT or MRI scans.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04965454

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

Recruiting
PHASE2Ages 18+Interventional
Queen's Medical Center
~80 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Fluorine-18 fluorocholine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lack of Objective Response
Measured over 16 weeks

Conditions

Hepatocellular Carcinoma Non-resectable

Explore related trials

Hepatocellular Carcinoma

NCT04965454

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Queen's Medical Center

    Honolulu, Hawaiistudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sandi A Kwee, MD, PhD · PRINCIPAL_INVESTIGATOR · The Queen's Medical Center

Who to contact

Abrar M Al-Adhmi, BS
[email protected]
808-691-7429
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Lack of Objective Response16 weeks

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