18F-Fluciclovine for Large Brain Metastases Treated with Radiation

This study is investigating whether a new imaging agent, 18F-fluciclovine, can help doctors see how well large brain metastases (cancers that have spread to the brain) are responding to radiation therapy. You may be able to join if you are an adult (18 years or older) with a confirmed diagnosis of brain metastases, have at least one untreated brain tumor larger than 2 cm, and are planning to receive a specific type of radiation therapy called Stereotactic Radiosurgery (SSRS). The study will measure changes in how well PET/CT and MRI scans detect these tumors, and changes in how much of the 18F-fluciclovine the tumors absorb. The study aims to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.
What's involved
You will receive a standard dose of 18F-fluciclovine intravenously after fasting for at least four hours. You will then undergo PET/CT brain imaging.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 1 year, to measure changes in imaging results.

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NCT04689048

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

Recruiting
PHASE1Ages 18+InterventionalPrevention
Baptist Health South Florida
~20 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:18F fluciclovine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in sensitivity for PET/CT
Measured over through study completion, an average of 1 year
+2 more outcomes measured
Brain Metastases, Adult
Brain Metastases
Brain Cancer
1 sites across 1 states
Florida1
  • Rupesh R Kotecha, MD · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute (MCI) at Baptist Health, Inc.

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  • Change in sensitivity for PET/CTthrough study completion, an average of 1 year

    Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS.

  • Change in sensitivity for MRIthrough study completion, an average of 1 year

    To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

  • Change in the standardized uptake value (SUV) parametersthrough study completion, an average of 1 year

    To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.