Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Study acronym: CONCORDANT

StatusRecruiting

PhasePhase 2

SponsorBaptist Health South Florida

Started2023-01-10

View on ClinicalTrials.gov ↗

Amendment history

2025-11-26

2 amendments v6-v7

2 re-verifications since 2024-10-17, no change to tracked fields

2024-07-03

Study Status v5

Primary completion date2024-06-30→2030-01

Completion date2025-06-30→2030-01

2023-12-26

Study Status, Contacts/Locations v4

Re-verified, no change to tracked fields

2023-02-08

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2023-01→confirmed 2023-01-10

Study sitesdetails revised at 1 of 1 site

2023-01-03

Study Status v2

Start date2022-12→2023-01

2022-11-08

Study Status v1

Start date2022-10-01→2022-12

2022-09-21

Original filing

Baptist Health South Florida

27 trials monitored

See 3 trials at risk

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.

Trial Details

NCT Number	NCT05554302
Lead Sponsor	Baptist Health South Florida Collaborators: Blue Earth Diagnostics
Conditions	Brain Metastases, Brain Cancer
Enrollment	20 participants
Start Date	2023-01-10
Primary Completion	2030-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-01