At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
18F fluciclovinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating 18F fluciclovine for Brain Metastases. Completed, enrolled 151 participants across 19 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Metastases
CountriesUnited States
CollaboratorsPrecision For Medicine
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartOct 2020
Primary CompletionJun 2023
TodayJul 2026
First PostedJun 1, 2020
Enrollment StartOct 26, 2020
Primary CompletionJun 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.1 years ago
Interventions
18F fluciclovinedrug
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus