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NCT04410367 · ClinicalTrials.gov registry record · Phase 2
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
A Phase 2 study, sponsored by Blue Earth Diagnostics.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT04410367: Completed Phase 2 study, sponsored by Blue Earth Diagnostics.
NCT04410367 is a Phase 2 study that has completed, run by Blue Earth Diagnostics. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410367, a Phase 2 study, has completed, sponsored by Blue Earth Diagnostics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
Primary Outcome
Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity. Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were t
Interventions
- DRUG 18F fluciclovine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 2 |
What the finished NCT04410367 record still lists
NCT04410367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which 18F fluciclovine is the first listed.
NCT04410367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04410367 about?
NCT04410367 is a clinical study titled "Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)". An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
What is the current status of trial NCT04410367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2020-08-31. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04410367?
The interventions under investigation include: 18F fluciclovine (DRUG).
Who is sponsoring clinical trial NCT04410367?
This trial is sponsored by Blue Earth Diagnostics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04410367's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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