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Fluorine-18 Fluorocholine PET/CT for Liver Cancer (ExTRACT-HCC Trial)

Phase 2

Recruiting

Led By Sandi A Kwee, MD, PhD

Research Sponsored by Queen's Medical Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Barcelona Clinic Liver Cancer Stage B or C

Age 18 years or older (no upper limit of age)

Must not have

Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure

Weight > 500 lbs (PET/CT limit)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether PET/CT and genomic liquid biopsy can predict whether a patient will respond to therapy for inoperable hepatocellular carcinoma.

Who is the study for?

This trial is for adults with inoperable liver cancer (Hepatocellular Carcinoma) who are under a medical oncologist's care, have certain levels of liver function and no serious conditions that would affect their ability to undergo imaging. Pregnant or lactating women and those on non-targeted cancer therapies cannot participate.

What is being tested?

The study tests if PET/CT scans using fluorine-18 fluorocholine can predict the effectiveness of immune-checkpoint inhibitor therapy in patients after 16 weeks. It also looks at genomic markers from liquid biopsies as potential predictors.

What are the potential side effects?

While this trial focuses on diagnostic procedures rather than treatment side effects, typical risks may include discomfort from the PET/CT scan and potential reactions to the tracer used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer is at an intermediate or advanced stage.

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I am 18 years old or older.

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My liver function is relatively good.

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My liver cancer diagnosis follows the latest expert guidelines.

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My kidneys work well enough to clear at least 40 mL/min of creatinine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that makes it hard for me to undergo imaging tests.

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My weight is under 500 lbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lack of Objective Response

Secondary study objectives

Disease Control

Objective Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tested with BiomarkersExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met