Study of 18F-Fluciclovine PETCT Imaging for Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Led by Baptist Health South Florida · Updated on 2026-04-22
20
Participants Needed
1
Research Sites
39 weeks
Total Duration
AI-Summary
What this Trial Is About
Brain metastases occur when cancer spreads to the brain and are a common complication in cancer patients. Researchers are studying a new imaging agent called 18F-fluciclovine to see if it can detect which patients respond to radiation therapy. The study also aims to monitor changes in the treated brain metastases over time using this imaging agent.
Participants will receive three 18F-fluciclovine PETCT brain scans before treatment, during treatment, and after treatment. The 18F-fluciclovine, also known as Axumin, is given as an intravenous injection with a maximum undiluted volume of 5 mL, followed by a saline flush. Patients must fast for at least four hours before injection, and PET images will be collected and analyzed to assess treatment response.
During the study, participants will undergo PETCT and MRI scans at multiple time points up to one year to evaluate changes in imaging sensitivity and standardized uptake value SUV parameters. Researchers will compare PET and MRI results over time to understand the effects of radiation therapy on brain metastases. Patient safety and treatment response will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Research Team
R
Rupesh C Kotecha, MD
K
Kristy Reyes
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
18F‑Fluciclovine PET/CT plus MRI
Standard MRI imaging pathway
What it is
An investigational imaging approach combining 18F‑fluciclovine PET/CT with MRI in patients with untreated brain metastases larger than 2 cm
Contrast‑enhanced MRI remains the standard imaging pathway for detecting and planning treatment of brain metastases
Role in trial
Tested imaging method for lesion characterization in this study
Represents usual imaging for comparison in clinical practice
Primary use
To characterize untreated large brain metastases and support radiosurgery planning
To detect and delineate brain metastases for diagnosis and treatment planning
How it is performed
Patients receive 18F‑fluciclovine injection followed by combined PET/CT and MRI imaging
Undergoes MRI with intravenous contrast without PET tracer administration
Evidence status
Early-phase pilot data show promising diagnostic accuracy in distinguishing tumor progression from treatment effects
MRI is well established for detecting metastases but has limited specificity for distinguishing progression from radiation effects
Important risks
Small radiation exposure from PET/CT tracer and CT scan; risk associated with intravenous tracer injection
Potential contrast agent risks such as allergic reaction or nephrogenic systemic fibrosis in susceptible individuals
Important limitations
Small early‑phase single‑group study; availability and interpretation criteria for 18F‑fluciclovine PET/CT are limited
High sensitivity but limited specificity for treatment‑related changes versus tumor progression
Patient impact
May improve diagnostic confidence in distinguishing progression from treatment effects and guide appropriate therapy decisions
High sensitivity helps detect brain lesions but diagnostic uncertainty may lead to delays or unnecessary interventions
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Male or female, age 18 years or older
Eastern Cooperative Oncology Group performance status of 0 to 2
Confirmed diagnosis of brain metastases with at least one untreated lesion larger than 2 cm
Planned treatment with staged stereotactic radiosurgery (SSRS)
Negative serum pregnancy test within 14 days for women of childbearing potential
Use of highly effective contraception for at least 4 weeks prior and during study participation for females of reproductive potential
You will not qualify if you...
Previous anaphylactic reaction to 18F-fluciclovine
Evidence of leptomeningeal disease
Prior whole-brain radiation therapy
Contraindications to MRI, such as having a pacemaker
Pregnant women at the time of 18F-fluciclovine administration
Breastfeeding women unwilling to stop for 24 hours after imaging
Major medical illness or psychiatric/cognitive impairments that prevent study completion or informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 1 year
Participants receive three 18F-fluciclovine PET/CT brain scans before, during, and after staged stereotactic radiosurgery treatment. The scans involve intravenous injection of 18F-fluciclovine and brain imaging to assess brain metastases.
Evaluation of 18F-Fluciclovine PET Imaging for Brain Metastasis Response After Stereotactic Radiosurgery
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Study of High Dose Fractionated Stereotactic Radiation Therapy for Treating Brain Metastases Using Modern Equipment
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Phase II Study of Nivolumab, Ipilimumab, and Cabozantinib for Untreated Brain Metastases from Renal Cell Carcinoma
Phase II Study of Tucatinib and Ado-trastuzumab Emtansine T-DM1 for HER2-positive Metastatic Solid Tumors with Brain Metastases
Study on Sparing the Hippocampus During Whole Brain Radiotherapy to Protect Memory in Patients with Brain Metastases
Phase 2 Study Testing Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Adults With Untreated Brain Metastases From Non-Small Cell Lung Cancer
Phase II Study of Stereotactic Radiosurgery for Brain Metastases in Adults with Small Cell Lung Cancer
Evaluating Osimertinib With Early Stereotactic Radiosurgery Versus Osimertinib Alone in Patients With EGFR-Mutated NSCLC and Asymptomatic Brain Metastases
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Published Research Related To This Trial
Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation.
Rupesh Kotecha, Mariam Aboian, Seyed Ali Nabavizadeh...