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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
ExTRACT-HCC Trial 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.Check my eligibility
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.See study design
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.
ExTRACT-HCC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ExTRACT-HCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lack of Objective Response
Secondary outcome measures
Disease Control
Objective Response
ExTRACT-HCC 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.
Find a Location
Who is running the clinical trial?
Queen's Medical CentreLead Sponsor
11 Previous Clinical Trials
1,851 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,825 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Queen's Medical CenterLead Sponsor
21 Previous Clinical Trials
4,782 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one tumor that can be measured on a scan.My doctor thinks I should get immune therapy due to past treatment failure and my current health status.I have a health condition that makes it hard for me to undergo imaging tests.My liver cancer is at an intermediate or advanced stage.I am 18 years old or older.I am currently not on any non-targeted cancer treatments but can be in an ICI trial.My liver function is relatively good.I am not pregnant or breastfeeding.My weight is under 500 lbs.My liver cancer diagnosis follows the latest expert guidelines.My kidneys work well enough to clear at least 40 mL/min of creatinine.
Research Study Groups:
This trial has the following groups:- Group 1: Tested with Biomarkers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other trials have been conducted using Fluorine-18 fluorocholine as a research subject?
"Presently, 8 clinical trials are being conducted that focus on Fluorine-18 fluorocholine. None of those initiatives have advanced to Phase 3 yet; however there are 33 sites across the world conducting research in this area, with most based in Honolulu, Hawaii."
Answered by AI
Has the FDA sanctioned Fluorine-18 fluorocholine yet?
"We have deemed Fluorine-18 fluorocholine a 2 on the Power scale, as this is merely a Phase 2 trial, indicating that only preliminary safety data has been collected and no studies of efficacy are available."
Answered by AI
Are there still spots available in this research project for individuals?
"Affirmative. Clinicaltrials.gov substantiates that this medical trial, which was initially advertised on March 28th 2022, is actively seeking participants. A total of 80 individuals are needed to be recruited from a single location."
Answered by AI
How many participants are actively engaging in this research?
"Indeed, the data on clinicaltrials.gov reveals that this research is actively recruiting participants. It was first published on March 28th of 2022 and has been updated since then; 80 patients are being sought from a single medical centre."
Answered by AI
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