Status:
COMPLETED
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Lead Sponsor:
Blue Earth Diagnostics
Collaborating Sponsors:
Precision For Medicine
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 bra...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
- Previous history of solid tumor brain metastasis of any origin
- Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
- 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 biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC
Exclusion
- 1\. Patients with a history of active hematological malignancy
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04410133
Start Date
October 26 2020
End Date
June 5 2023
Last Update
August 28 2025
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
University of California, San Francisco
San Francisco, California, United States, 94118
4
John Wayne Cancer Institute at Providence St. John's Health Center
Santa Monica, California, United States, 90404