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NCT04410133 · ClinicalTrials.gov registry record · Phase 3
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
A Phase 3 study, sponsored by Blue Earth Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT04410133: Completed Phase 3 study, sponsored by Blue Earth Diagnostics.
NCT04410133 is a Phase 3 study that has completed, run by Blue Earth Diagnostics. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410133, a Phase 3 study, has completed, sponsored by Blue Earth Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study Summary
An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy
Primary Outcome
Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
Interventions
- DRUG 18F fluciclovine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2023-06-05 |
| Phase | Phase 3 |
What the finished NCT04410133 record still lists
NCT04410133 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which 18F fluciclovine is the first listed.
NCT04410133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04410133 about?
NCT04410133 is a clinical study titled "Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases". An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy
What is the current status of trial NCT04410133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2020-10-26. Estimated completion is 2023-06-05.
What interventions are being tested in trial NCT04410133?
The interventions under investigation include: 18F fluciclovine (DRUG).
Who is sponsoring clinical trial NCT04410133?
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 NCT04410133's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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