{"entity":{"id":"nct04410133","kind":"trial","name":"Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases","aka":[],"tldr":"A phase 3 trial of Fluciclovine F-18 in Brain metastases, run by Blue Earth Diagnostics, completed.","summary":"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.\n\nLinked 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.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04410133","url":"https://clinicaltrials.gov/study/NCT04410133"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["secondary-brain-tumours"],"sections":[],"technologies":[],"targets":[],"drugs":["fluciclovine-f18"],"companies":["blue-earth-diagnostics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04410133","phase":"3","setting":"An Open-label, Single-arm, Single-dose, 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","sponsor":"Blue Earth Diagnostics","started":"2020-10-26","startedType":"actual","yearReported":2025,"enrolled":151,"enrolledBasis":"registry","outcomes":[{"endpoint":"Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level","primary":true,"unit":"%","arms":[{"name":"Reader 1 - Positive Percent Agreement (PPA)","n":42,"value":23.8,"note":"95% CI 12.1 to 39.5; Figures from the ClinicalTrials.gov results section (first posted 2025-08-28), not from a publication"},{"name":"Reader 2 - Positive Percent Agreement (PPA)","n":41,"value":34.1,"note":"95% CI 20.1 to 50.6"},{"name":"Reader 3 - Positive Percent Agreement (PPA)","n":41,"value":36.6,"note":"95% CI 22.1 to 53.1"},{"name":"Reader 1 - Negative Percent Agreement (NPA)","n":109,"value":82.6,"note":"95% CI 74.1 to 89.2"},{"name":"Reader 2 - Negative Percent Agreement (NPA)","n":110,"value":70.9,"note":"95% CI 61.5 to 79.2"},{"name":"Reader 3 - Negative Percent Agreement (NPA)","n":110,"value":70.9,"note":"95% CI 61.5 to 79.2"}],"source":"https://clinicaltrials.gov/study/NCT04410133?tab=results"}]},"route":"/trials/nct04410133/","neighbours":{"cancer":[{"id":"secondary-brain-tumours","kind":"cancer","name":"Brain metastases (secondary brain tumours)","route":"/cancers/secondary-brain-tumours/"}],"drug":[{"id":"fluciclovine-f18","kind":"drug","name":"Fluciclovine F-18","route":"/drugs/fluciclovine-f18/"}],"company":[{"id":"blue-earth-diagnostics","kind":"company","name":"Blue Earth Diagnostics (Bracco)","route":"/companies/blue-earth-diagnostics/"}]}}