Status:
COMPLETED
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Lead Sponsor:
Blue Earth Diagnostics
Collaborating Sponsors:
Precision For Medicine
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Recurren...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Previous history of solid tumor brain metastasis of any origin
- Histopathological confirmation of the primary solid tumor or a metastatic site
- Previous radiation therapy of brain metastatic lesion(s)
- A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
- Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy
Exclusion
- 1\. Patients with a history of active hematological malignancy
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04410367
Start Date
August 31 2020
End Date
December 31 2021
Last Update
July 20 2025
Active Locations (9)
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1
John Wayne Cancer Institute at Providence St. John's Health Center
Santa Monica, California, United States, 90404
2
Yale School of Medicine
New Haven, Connecticut, United States, 06519
3
Miami Cancer Institute
Miami, Florida, United States, 33176
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70131