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

Brain Metastases Clinical Trial

— REVELATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410133
• Other study ID #: BED-FLC-312
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2020
• Est. completion date: June 5, 2023

Study information

• Verified date: July 2023
• Source: Blue Earth Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 5, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan
United States	Medical College of Georgia, Augusta University	Augusta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospital Cleveland	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
United States	West Virgina University Cancer Institute	Morgantown	West Virginia
United States	Yale School of Medicine	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	NYU Langone Health	New York	New York
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Washington University School of Medicine-Center for Clinical Imaging Research	Saint Louis	Missouri
United States	Center for Quantitative Cancer Imaging at Huntsman Cancer Institute	Salt Lake City	Utah
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

Sponsors (2)

Lead Sponsor	Collaborator
Blue Earth Diagnostics	Precision For Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases	PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.	6 months
Primary	Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases	NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.	6 months
Secondary	Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases	Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.	6 months
Secondary	Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases	Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.	6 months
Secondary	Treatment-emergent adverse events	Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.	48 hours