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18F-DCFPyL PET/CT Scan for Liver Cancer

Phase 2
Recruiting
Led By Freddy E Escorcia, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to take oral medication and be willing to adhere to the study intervention regimen
Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured
Must not have
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post ablation, disease progression
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new tracer to see if it can better identify hepatocellular cancer in people.

Who is the study for?
Adults who may have hepatocellular carcinoma (HCC) based on previous imaging, can take oral meds and follow the study plan. They must use contraception if of childbearing potential. Excluded are those with severe claustrophobia, high creatinine levels, unstable health conditions, or weight over 350 lbs.
What is being tested?
The trial is testing a new radiotracer called 18F-DCFPyL for identifying HCC compared to the standard tracer 18F-FDG. Participants will undergo PET/CT scans using these tracers and continue with their usual cancer treatments.
What are the potential side effects?
Potential side effects from the tracers could include allergic reactions or discomfort at injection site. The CT scan involves exposure to radiation which carries a risk of cancer but is considered low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and will follow the study's treatment plan.
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I had hepatitis C but have been treated and cured.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have chronic hepatitis B but am on treatment that keeps the virus undetectable.
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My liver cancer is highly suspected based on advanced imaging results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe claustrophobia that doesn't improve with anxiety medication.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- and post-treatment hcc treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- and post-treatment hcc treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Positive predictive value
Secondary study objectives
Change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment
Lesion level sensitivity, specificity and positive predictive value

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: 1/Baseline and Post-treatment ImagingExperimental Treatment4 Interventions
18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810
CT
2017
Completed Phase 3
~3270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,951 Total Patients Enrolled
104 Trials studying Liver Cancer
26,538 Patients Enrolled for Liver Cancer
Freddy E Escorcia, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

F18-DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT05009979 — Phase 2
Liver Cancer Research Study Groups: 1/Baseline and Post-treatment Imaging
Liver Cancer Clinical Trial 2023: F18-DCFPyL Highlights & Side Effects. Trial Name: NCT05009979 — Phase 2
F18-DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT05009979 — Phase 2
~11 spots leftby Jun 2025
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