Trials / Completed
CompletedNCT04410367
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Blue Earth Diagnostics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18F fluciclovine | 18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus |
Timeline
- Start date
- 2020-08-31
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2020-06-01
- Last updated
- 2025-07-20
- Results posted
- 2023-08-01
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04410367. Inclusion in this directory is not an endorsement.