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NCT04176497 · ClinicalTrials.gov registry record · Phase 2
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04176497: Clinical Trial Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04176497 is a Phase 2 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. 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
NCT04176497, a Phase 2 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.
Primary Outcome
Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicat
Interventions
- DRUG 68Ga-HBED-CC-PSMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2024-10-25 |
| Phase | Phase 2 |
Why NCT04176497 stopped before completion
NCT04176497 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 1 intervention - of which 68Ga-HBED-CC-PSMA is the first listed.
NCT04176497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04176497 about?
NCT04176497 is a clinical study titled "PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study". The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current pla...
What is the current status of trial NCT04176497?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-07-16. Estimated completion is 2024-10-25.
What interventions are being tested in trial NCT04176497?
The interventions under investigation include: 68Ga-HBED-CC-PSMA (DRUG).
Who is sponsoring clinical trial NCT04176497?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04176497'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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