Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

Completed · Phase 3

Conditions studied: Brain Metastases

In brief

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

Key facts

Study ID

NCT04410133

Run by

Blue Earth Diagnostics

People needed

151

Starts

2020-10-26

Expected to finish

2023-06-05

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with a history of active hematological malignancy

Where it is running

• 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

Full record on ClinicalTrials.gov

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