RecruitingPhase 2NCT05554302

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

Sponsor

Baptist Health South Florida

Enrollment

20 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

Brain Metastases Brain Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special PET scan with a radioactive tracer called 18F-Fluciclovine to better understand brain metastases (cancer that has spread to the brain) in people scheduled for surgery to remove the tumors. The goal is to help doctors better plan radiation treatment after surgery. **You may be eligible if:** - You are 18 or older - You have brain metastases confirmed by imaging - You are scheduled for surgery to remove at least one brain metastasis - You are also planned for radiation therapy (stereotactic radiosurgery) after surgery - You are willing to use contraception if you are of reproductive potential **You may NOT be eligible if:** - You have had a severe allergic reaction to 18F-Fluciclovine before - You have leptomeningeal disease (cancer spreading along the lining of the brain or spinal cord) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUG18F-Fluciclovine

Patients will receive 5-mCi dose (+/- 20%) of 18F-Fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-Fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-Fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Locations(1)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05554302

Related Trials

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

NCT073265664 locations

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique

NCT050459502 locations

Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)

NCT072106321 location

Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

NCT046890481 location

Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1

NCT074625071 location