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NCT02371031 · ClinicalTrials.gov registry record · Phase 1
FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02371031: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT02371031 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02371031, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving surgical planning and providing non-invasive prognostic information in patients with gliomas that have substantial non-enhancing regions. The results will be used to develop larger adequately powered studies.
Primary Outcome
We will consider our primary endpoint successful if FDOPA-PET changes the surgical plan in at least 4 of the 20 patients (20%), a much lower margin than previously reported with \[C-11\]methionine which is on the order of 60-70% of cases. When safe and feasible, these discrepant areas identified on FDOPA-PET/MRI will undergo tissue sampling. However, tissue sampling of discrepant areas may not be possible in all patients, and this decision will be made by the treating neurosurgeon.
Interventions
- DEVICE PET/MRI
- PROCEDURE Surgical resection (standard of care)
- DRUG 6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
Why NCT02371031 stopped before completion
NCT02371031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which PET/MRI is the first listed.
NCT02371031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02371031 about?
NCT02371031 is a clinical study titled "FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas". This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving surgical planning and providing non-invasive prognostic information in patients with gliomas that have substantial non-enhancing regions. The results will be used to develop larger adequately powered studie...
What is the current status of trial NCT02371031?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2015-03. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02371031?
The interventions under investigation include: PET/MRI (DEVICE), Surgical resection (standard of care) (PROCEDURE), 6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine (DRUG).
Who is sponsoring clinical trial NCT02371031?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02371031's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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