18F-Fluciclovine PET Imaging for Brain Metastasis

This study is for adults (18 and older) who have had surgery for brain metastasis (cancer that has spread to the brain) and are also planning to have stereotactic radiosurgery (a type of radiation therapy). The study aims to see if a special imaging agent called 18F-Fluciclovine, used with a PET/CT scan, can help doctors better see the extent of the tumor after surgery and detect if the cancer returns. This imaging agent is still being investigated for use in brain metastases. The study will measure how well the imaging agent helps define the tumor area and how much of the agent the tumor takes up, at 3 weeks, 6 months, and 12 months after treatment. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive an intravenous injection of 18F-Fluciclovine after fasting for at least four hours, followed by a PET/CT brain scan.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in tumor volume and PET scan results at 3 weeks, 6 months, and 12 months.

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NCT05554302

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Baptist Health South Florida
~20 participants
Updated 2025-12-01 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 conformality index of tumor target volume delineation
Measured over 3 weeks, 6 and 12 months
+1 more outcome measured
Brain Metastases
Brain Cancer
1 sites across 1 states
Florida1
  • Rupesh R Kotecha, M.D. · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute/Baptist Health South Florida

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Eligibility criteria

Inclusion

Male condom plus spermicide
Cap plus spermicide
Diaphragm plus spermicide
Copper T
Progesterone T
Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
Implants
Hormone shot or injection
Combined pill
Mini-pill
Patch
Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
Radiation-induced oophorectomy with last menses \> 1 year ago
Chemotherapy-induced menopause with \>1 year interval since last menses
Surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Change in conformality index of tumor target volume delineation3 weeks, 6 and 12 months

    The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.

  • Change in PET scan standardized uptake value (SUV) parameters3 weeks, 6 and 12 months

    The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.