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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 Oct 20, 2026, 11:55 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 26, 2020 (Actual)
Primary completion
Jun 5, 2023 (Actual)
Completion
Jun 5, 2023 (Actual)
Last update posted
Aug 28, 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 28, 2025 · Synced Oct 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04410133 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →