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NCT03930173 · ClinicalTrials.gov registry record · Early Phase 1
18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis
A Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT03930173: Completed Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT03930173 is a Early Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 18 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03930173, a Early Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether 18F-fluciclovine PET/CT of the brain, is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive. 18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.
Primary Outcome
The accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression will be reported. Accuracy will be assessed via receiver operating characteristic curve analysis.
Interventions
- DRUG 18F-fluciclovine
- DEVICE PET/CT of the brain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2021-03-01 |
| Phase | Early Phase 1 |
What the finished NCT03930173 record still lists
NCT03930173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which 18F-fluciclovine is the first listed.
NCT03930173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03930173 about?
NCT03930173 is a clinical study titled "18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis". The purpose of this study is to evaluate whether 18F-fluciclovine PET/CT of the brain, is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive. 18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then ...
What is the current status of trial NCT03930173?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2019-07-02. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT03930173?
The interventions under investigation include: 18F-fluciclovine (DRUG), PET/CT of the brain (DEVICE).
Who is sponsoring clinical trial NCT03930173?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03930173's enrollment target sits among peer trials
18 1316th of 2000 higher than 651 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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