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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post ablation, disease progression
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post ablation, disease progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post ablation, disease progression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive predictive value
Secondary outcome measures
Change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment
Lesion level sensitivity, specificity and positive predictive value
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
~1370
CT
2017
Completed Phase 3
~3200
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,471 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Freddy E Escorcia, M.D.Principal InvestigatorNational Cancer Institute (NCI)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe claustrophobia that doesn't improve with anxiety medication.I can take pills and will follow the study's treatment plan.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am a candidate for treatments targeting specific areas of my cancer.I had hepatitis C but have been treated and cured.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I can understand and am willing to sign the consent form.I am not pregnant.I have chronic hepatitis B but am on treatment that keeps the virus undetectable.I am HIV positive, on treatment, and my viral load is undetectable.I agree to use birth control or abstain from sex during and for 2 months after the study.My liver cancer is highly suspected based on advanced imaging results.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Baseline and Post-treatment Imaging
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.
How many participants are partaking in this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that recruitment for this trial is underway, having been first posted on June 20th 2022 and last edited November 19th 2022. 50 individuals are needed to join from 2 research centres."
Answered by AI
Is this experiment still recruiting participants?
"That is accurate. Per the information found on clinicaltrials.gov, this medical investigation began recruitment efforts in June and has since been updated in November of 2022 with a goal to enlist 50 people from 2 distinct research facilities."
Answered by AI
What safety measures have been established for F18-DCFPyL treatment?
"Our team at Power has assigned F18-DCFPyL a score of 2, as this is only in its second clinical trial phase. Though it's safety profile has been ascertained, there are no existing data points to back up the efficacy of this drug."
Answered by AI
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