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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration. 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:

1. Patients with a history of active hematological malignancy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04410133
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Blue Earth Diagnostics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Arms & Interventions

Arms

Experimental: Patients

Single intravenous administration of 18F fluciclovine for PET Scan

Interventions

Drug: - 18F fluciclovine

18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

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University of Alabama at Birmingham

Birmingham, Alabama, 35233

St. Joseph's Hospital and Medical Center, Phoenix, Arizona

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St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

University of California, San Francisco, San Francisco, California

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University of California, San Francisco

San Francisco, California, 94118

Santa Monica, California

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John Wayne Cancer Institute at Providence St. John's Health Center

Santa Monica, California, 90404

Yale School of Medicine, New Haven, Connecticut

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Yale School of Medicine

New Haven, Connecticut, 06519

Miami, Florida

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Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176

Augusta, Georgia

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Medical College of Georgia, Augusta University

Augusta, Georgia, 30912

Ochsner Clinic Foundation, New Orleans, Louisiana

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Ochsner Clinic Foundation

New Orleans, Louisiana, 70131

Johns Hopkins Hospital, Baltimore, Maryland

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Johns Hopkins Hospital

Baltimore, Maryland, 21287

Ann Arbor, Michigan

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109

Henry Ford Hospital, Detroit, Michigan

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Henry Ford Hospital

Detroit, Michigan, 48202

Saint Louis, Missouri

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Washington University School of Medicine-Center for Clinical Imaging Research

Saint Louis, Missouri, 63110

NYU Langone Health, New York, New York

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NYU Langone Health

New York, New York, 10016

University Hospital Cleveland, Cleveland, Ohio

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University Hospital Cleveland

Cleveland, Ohio, 44106

Cleveland Clinic, Cleveland, Ohio

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Cleveland Clinic

Cleveland, Ohio, 44195

University of Pennsylvania Health System, Philadelphia, Pennsylvania

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Houston, Texas

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The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Salt Lake City, Utah

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Center for Quantitative Cancer Imaging at Huntsman Cancer Institute

Salt Lake City, Utah, 84112

West Virgina University Cancer Institute, Morgantown, West Virginia

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West Virgina University Cancer Institute

Morgantown, West Virginia, 26506

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