Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
NCT ID: NCT04410367
Last Updated: 2025-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2020-08-31
2021-12-31
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 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus
Interventions
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18F fluciclovine
18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (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
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 craniotomy
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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Principal Investigators
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Eugene Teoh, MD
Role: STUDY_DIRECTOR
Blue Earth Diagnostics
Rupesh Kotecha, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute
Locations
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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
Miami, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 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
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
Salt Lake City, Utah, 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-219
Identifier Type: -
Identifier Source: org_study_id
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