NCT04410133

Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Blue Earth Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DRUG	18F fluciclovine	18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

Timeline

• Start date: 2020-10-26
• Primary completion: 2023-06-05
• Completion: 2023-06-05
• First posted: 2020-06-01
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study