RecruitingPhase 1NCT06048094

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)


Sponsor

Baptist Health South Florida

Enrollment

46 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a specialized type of PET scan (using a tracer called 18F-Fluciclovine that targets amino acid uptake) can better evaluate brain metastases before and after stereotactic radiosurgery (SRS) — a precise, highly focused radiation treatment. Better imaging may help doctors tell the difference between tumor growth and radiation side effects. **You may be eligible if...** - You have cancer that has spread to the brain (brain metastases) - All brain lesions are 2 cm or smaller - You are scheduled to receive stereotactic radiosurgery (SRS) - You are in good enough health (ECOG 0–2) **You may NOT be eligible if...** - You have had a prior severe allergic reaction to 18F-Fluciclovine (the scan tracer) - There is evidence of cancer spreading along the lining of the brain (leptomeningeal disease) - You have previously received whole-brain radiation - You cannot undergo MRI safely 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

Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection 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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NCT06048094


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