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NCT05009979 · ClinicalTrials.gov registry record · Phase 2
18F-DCFPyL PET/CT in Hepatocellular Carcinoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT05009979: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT05009979 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05009979, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: A radiotracer (or tracer) is a radioactive substance. It is used in Positron Emission Tomography (PET) imaging to help see specific sites in the body. Researchers want to learn if a new tracer can help them better identify hepatocellular cancer (HCC) in people. Objective: To learn if a radiotracer called piflufolastat F-18 (18F-DCFPyL), can identify sites of HCC better than current standard imaging. Eligibility: Adults aged 18 years and older who may have HCC based on previous standard imaging. Design: Participants will be screened with a medical history, physical exam, and blood tests. They will have a computed tomography (CT) and/or magnetic resonance imaging (MRI) scan. Participants will have a whole-body positron emission tomography (PET/CT) scan. The PET and CT scanners use x-rays to make pictures of the inside of the body. The PET uses a tracer to help make the pictures. Participants will get an intravenous (IV) injection of 18F-DCFPyL 1 hour before the scan. Within two weeks, participants will have a Fludeoxyglucose F 18 (18F-FDG) PET/CT scan. 18F-FDG is a commonly used tracer. They will get 18F-FDG via IV 1 hour before the scan. Participants will have a CT/magnetic resonance imaging (MRI) within 2 months of the first 18F-DCFPyL PET/CT. Participants will have standard treatment for their cancer. During treatment, they will have a tumor biopsy. If the biopsy shows they do not have HCC, they will be removed from the study. For participants who have HCC and their cancer was identified in the 18F-DCFPyL PET/CT, they will have a second 18F-DCFPyL PET/CT and 18F-FDG PET/CT. Participants will have follow-up visits every 3 months for 2 years. Then they will have yearly visits for 3 years.
Primary Outcome
Positive predictive value is defined as the proportion of histopathologically positive lesions. Positron emission tomography (PET) positivity was measured by the maximum standardized uptake (SUVmax) value. The 95% confidence intervals of the positive predictive value of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by rand
Interventions
- DEVICE MRI
- PROCEDURE Tumor biopsy
- DRUG F18-FDG
- DEVICE CT
- DRUG F18-DCFPyL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2024-11-20 |
| Phase | Phase 2 |
Why NCT05009979 stopped before completion
NCT05009979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which MRI is the first listed.
NCT05009979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05009979 about?
NCT05009979 is a clinical study titled "18F-DCFPyL PET/CT in Hepatocellular Carcinoma". Background: A radiotracer (or tracer) is a radioactive substance. It is used in Positron Emission Tomography (PET) imaging to help see specific sites in the body. Researchers want to learn if a new tracer can help them better identify hepatocellular cancer (HCC) in people. Objective: To learn if ...
What is the current status of trial NCT05009979?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2023-01-18. Estimated completion is 2024-11-20.
What interventions are being tested in trial NCT05009979?
The interventions under investigation include: MRI (DEVICE), Tumor biopsy (PROCEDURE), F18-FDG (DRUG), CT (DEVICE), F18-DCFPyL (DRUG).
Who is sponsoring clinical trial NCT05009979?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05009979's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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