RecruitingPhase 1NCT04689048

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

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery


Sponsor

Baptist Health South Florida

Enrollment

20 participants

Start Date

Apr 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special PET scan using a tracer called 18F-fluciclovine (originally developed for prostate cancer) to better image large brain metastases before and after a staged radiation treatment, to help doctors tell apart live tumor from dead tissue (radiation necrosis). **You may be eligible if...** - You are 18 or older - You have confirmed brain metastases with at least one untreated lesion larger than 2 cm - You are scheduled for staged stereotactic radiosurgery (a precise form of radiation) - Your overall health is adequate (ECOG 0–2) - If you can become pregnant, you have a negative pregnancy test and agree to use contraception **You may NOT be eligible if...** - You have had a prior allergic reaction to 18F-fluciclovine - Your cancer has spread along the lining of the brain (leptomeningeal disease) - You are pregnant or breastfeeding 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.

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Interventions

DRUG18F fluciclovine

Patients will receive a standard 5 millicuries dose 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

Miami, Florida, United States

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NCT04689048


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