Viewing Study NCT05554302


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Ignite Modification Date: 2025-12-26 @ 2:44 AM
Study NCT ID: NCT05554302
Status: RECRUITING
Last Update Posted: 2025-12-01
First Post: 2022-09-16
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Sponsor: Baptist Health South Florida
Organization:

Study Overview

Official Title: Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Status: RECRUITING
Status Verified Date: 2025-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CONCORDANT
Brief Summary: 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: