Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
NCT ID: NCT04410133
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2020-10-26
2023-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients
Single intravenous administration of 18F fluciclovine for PET Scan
18F fluciclovine
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Interventions
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18F fluciclovine
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Previous history of solid tumor brain metastasis of any origin
3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
4. Previous radiation therapy of brain metastatic lesion(s)
5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
6. 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 Criteria
18 Years
ALL
No
Sponsors
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Precision For Medicine
INDUSTRY
Blue Earth Diagnostics
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
John Wayne Cancer Institute at Providence St. John's Health Center
Santa Monica, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Medical College of Georgia, Augusta University
Augusta, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine-Center for Clinical Imaging Research
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
University Hospital Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 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
West Virgina University Cancer Institute
Morgantown, West Virginia, United States
Countries
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References
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Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BED-FLC-312
Identifier Type: -
Identifier Source: org_study_id
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