Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
REVELATE
An Open-label, Single-arm, Single-dose, 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
1 other identifier
interventional
151
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2020
Typical duration for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2023
CompletedResults Posted
Study results publicly available
August 28, 2025
CompletedAugust 28, 2025
August 1, 2025
2.6 years
May 27, 2020
May 29, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level
Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Secondary Outcomes (16)
Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type
MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
- +11 more secondary outcomes
Study Arms (1)
Patients
EXPERIMENTALSingle intravenous administration of 18F fluciclovine for PET Scan
Interventions
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Blue Earth Diagnosticslead
- Precision For Medicinecollaborator
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of California, San Francisco
San Francisco, California, 94118, United States
John Wayne Cancer Institute at Providence St. John's Health Center
Santa Monica, California, 90404, United States
Yale School of Medicine
New Haven, Connecticut, 06519, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Medical College of Georgia, Augusta University
Augusta, Georgia, 30912, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70131, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Washington University School of Medicine-Center for Clinical Imaging Research
St Louis, Missouri, 63110, United States
NYU Langone Health
New York, New York, 10016, United States
University Hospital Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
West Virgina University Cancer Institute
Morgantown, West Virginia, 26506, United States
Related Publications (1)
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.
PMID: 34081125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Research and Development
- Organization
- Blue Earth Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 1, 2020
Study Start
October 26, 2020
Primary Completion
June 5, 2023
Study Completion
June 5, 2023
Last Updated
August 28, 2025
Results First Posted
August 28, 2025
Record last verified: 2025-08