Surgery, Stereotactic Radiosurgery, and Systemic Therapy in the Management of Operable Brain Metastasis.
Rupesh Kotecha, Manmeet S Ahluwalia, Vitaly Siomin...
https://pubmed.ncbi.nlm.nih.gov/35465884/Actively Recruiting
Led by Baptist Health South Florida · Updated on 2025-12-01
20
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying patients who have undergone surgery to remove brain metastases and are scheduled for stereotactic radiosurgery SRS afterward. The study aims to evaluate whether the imaging agent 18F-Fluciclovine, used alongside MRI, can better detect residual tumor tissue and identify recurrent disease that MRI alone might miss. This agent is investigational for imaging brain metastases. Participants will receive a 5-mCi dose of 18F-Fluciclovine through an intravenous injection after fasting for at least four hours. The PETCT scan using this agent will be performed at the time of SRS treatment, about 2 to 4 weeks after surgery, alongside the standard MRI. Patients will continue to have combined 18F-Fluciclovine PETCT and MRI scans during routine follow-ups to monitor tumor control, detect recurrence, and assess areas at risk. During the study, participants will undergo PETCT imaging sessions with 18F-Fluciclovine and MRI scans at baseline and at 3 weeks, 6 months, and 12 months. Researchers will measure changes in tumor volume delineation and PET scan uptake values to assess treatment response. Safety and tumor control will also be monitored, with follow-up assessments extending to at least one year. The total study duration varies by participant based on follow-up timing.
CONDITIONS
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
R
Rupesh R Kotecha, M.D.
A
Antoinette Pimentel
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Baptist Health South Florida
Lead Sponsor
Blue Earth Diagnostics
Collaborating Sponsor
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 | Investigational PET/CT (18F-Fluciclovine) | Current Standard: MRI-Only Imaging |
|---|---|---|
| What it is | A PET/CT scan using 18F-Fluciclovine, an amino acid radiotracer injected after surgery, to visualize and characterize brain metastases for radiosurgery treatment planning. | A contrast-enhanced MRI scan of the brain, currently used as the routine imaging method to define tumor targets and guide postoperative radiosurgery for brain metastases. |
| Role in trial or care | Investigational imaging method being tested to see if 18F-Fluciclovine PET/CT more clearly identifies post-surgical tumor margins than MRI alone. | Established standard imaging practice for identifying tumor boundaries and surgical cavity for planning stereotactic radiosurgery. |
| Primary use | To help define the volume and borders of brain metastasis after surgery by measuring radiotracer uptake, aiding in accurate radiosurgical planning. | Used to visualize brain lesions and surgical cavities, serving as the main basis for drawing radiosurgery target volumes. |
| How it is given or performed | A small amount of 18F-Fluciclovine is injected into a vein, and PET/CT imaging is performed up to 25 minutes after injection to scan the brain. | Standard brain MRI with intravenous contrast, using magnetic fields to generate detailed images of brain structures and surgical site. |
| Evidence status | Clinical research in gliomas and preliminary studies suggest that 18F-Fluciclovine PET may improve tumor margin visualization, but its benefit for brain metastases is under investigation and not yet established. | MRI is supported by guidelines and extensive experience for reliably identifying post-surgical tumor regions and surgical cavities; limitations can occur in areas of post-operative change. |
| Important limitations | Evidence for 18F-Fluciclovine PET/CT in post-surgical brain metastasis is still preliminary. Application may be limited by radiotracer availability, patient tolerance to injection, and lack of established protocols. | MRI can sometimes over- or underestimate tumor margins due to changes from surgery, leading to possible imprecision in radiosurgery planning. |
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.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of stereotactic radiosurgery (SRS) treatment approximately 2 to 4 weeks after brain metastasis resection.
1 visit (in-person)
Duration - Up to 12 months
Participants continue to undergo 18F-Fluciclovine PET/CT and MRI during routine follow-up to monitor tumor control, identify areas at risk for failure, and detect disease recurrence.
3 visits over 12 months (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/30046944/Baptist Health South Florida
Lead Sponsor
Blue Earth Diagnostics
Collaborating Sponsor