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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04410133

Public ClinicalTrials.gov record NCT04410133. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 10:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT04410133
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Blue Earth Diagnostics
Industry
Enrollment
151 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 25, 2020
Primary completion
Jun 4, 2023
Completion
Jun 4, 2023
Last update posted
Aug 27, 2025

2020 – 2023

United States locations

U.S. sites
19
U.S. states
16
U.S. cities
18
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233
St. Joseph's Hospital and Medical Center Phoenix Arizona 85013
University of California, San Francisco San Francisco California 94118
John Wayne Cancer Institute at Providence St. John's Health Center Santa Monica California 90404
Yale School of Medicine New Haven Connecticut 06519
Miami Cancer Institute at Baptist Health, Inc. Miami Florida 33176
Medical College of Georgia, Augusta University Augusta Georgia 30912
Ochsner Clinic Foundation New Orleans Louisiana 70131
Johns Hopkins Hospital Baltimore Maryland 21287
University of Michigan Rogel Cancer Center Ann Arbor Michigan 48109
Henry Ford Hospital Detroit Michigan 48202
Washington University School of Medicine-Center for Clinical Imaging Research St Louis Missouri 63110
NYU Langone Health New York New York 10016
University Hospital Cleveland Cleveland Ohio 44106
Cleveland Clinic Cleveland Ohio 44195
University of Pennsylvania Health System Philadelphia Pennsylvania 19104
The University of Texas MD Anderson Cancer Center Houston Texas 77030
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute Salt Lake City Utah 84112
West Virgina University Cancer Institute Morgantown West Virginia 26506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04410133, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2025 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04410133 live on ClinicalTrials.gov.

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