Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
- Registration Number
- NCT04410133
- Lead Sponsor
- Blue Earth Diagnostics
- 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 brain metastases after radiation therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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
- Patients with a history of active hematological malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients 18F fluciclovine Single intravenous administration of 18F fluciclovine for PET Scan
- Primary Outcome Measures
Name Time Method Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases 6 months PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases 6 months NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
- Secondary Outcome Measures
Name Time Method Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases 6 months Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases 6 months Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Treatment-emergent adverse events 48 hours Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.
Trial Locations
- Locations (19)
West Virgina University Cancer Institute
🇺🇸Morgantown, West Virginia, United States
Medical College of Georgia, Augusta University
🇺🇸Augusta, Georgia, United States
John Wayne Cancer Institute at Providence St. John's Health Center
🇺🇸Santa Monica, California, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
University Hospital Cleveland
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine-Center for Clinical Imaging Research
🇺🇸Saint Louis, Missouri, United States
NYU Langone Health
🇺🇸New York, New York, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States