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A phase 3 trial of Fluciclovine F-18 in Brain metastases, run by Blue Earth Diagnostics, completed.
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases is a phase 3 interventional study registered as NCT04410133 by Blue Earth Diagnostics, with 151 participants recorded, started 2020-10-26 and reaching its primary completion in 2023-06-05. Interventions recorded: 18F fluciclovine. Conditions recorded: Brain Metastases.
Linked to the drug Fluciclovine F-18 because the registry names it among its interventions and Brain metastases among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
151 enrolled.
95% CI 12.1 to 39.5; Figures from the ClinicalTrials.gov results section (first posted 2025-08-28), not from a publication · 95% CI 20.1 to 50.6 · 95% CI 22.1 to 53.1 · 95% CI 74.1 to 89.2 · 95% CI 61.5 to 79.2 · 95% CI 61.5 to 79.2
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Levelprimary | Reader 1 - Positive Percent Agreement (PPA) | 42 | 23.8% | - | - | link |
| Reader 2 - Positive Percent Agreement (PPA) | 41 | 34.1% | ||||
| Reader 3 - Positive Percent Agreement (PPA) | 41 | 36.6% | ||||
| Reader 1 - Negative Percent Agreement (NPA) | 109 | 82.6% | ||||
| Reader 2 - Negative Percent Agreement (NPA) | 110 | 70.9% | ||||
| Reader 3 - Negative Percent Agreement (NPA) | 110 | 70.9% |
Shares Fluciclovine F-18 and the tag pipeline.
Shares Blue Earth Diagnostics (Bracco) and the tag pipeline.
Shares Blue Earth Diagnostics (Bracco) and the tag pipeline.
Shares Brain metastases (secondary brain tumours) and the tag pipeline.
Shares Brain metastases (secondary brain tumours) and the tag pipeline.
Shares Brain metastases (secondary brain tumours) and the tag pipeline.
Shares Fluciclovine F-18 and the tag pipeline.
Shares Brain metastases (secondary brain tumours) and the tag pipeline.