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

Study Overview
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Brief Summary
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This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.

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

Conditions
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Brain Metastases, Brain Cancer

Intervention / Treatment
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* Drug: 18F-Fluciclovine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3 Radiographic diagnosis of brain metastasis Patient planned for surgical intervention for at least 1 metastasis Patient planned for postoperative SRS Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-Fluciclovine PET/CT. Highly effective and acceptable forms of contraception are: 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 Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following: 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). Exclusion Criteria: Prior anaphylactic reaction to 18F-Fluciclovine Evidence of leptomeningeal disease Prior whole-brain radiation therapy Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) Pregnant at the expected time of 18F-fluciclovine administration Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT, MRI<br>All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure. | Drug: 18F-Fluciclovine<br>* Patients will receive 5-mCi dose (+/- 20%) of 18F-Fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-Fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-Fluciclovine 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in conformality index of tumor target volume delineation | 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. | 3 weeks, 6 and 12 months | 
| Change in PET scan standardized uptake value (SUV) parameters | 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. | 3 weeks, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to local failure | Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain metastases, Brain cancer, Stereotactic radiosurgery