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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT, MRI | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluciclovine | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
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:
Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupesh R Kotecha, M.D. | Contact | 17865962000 | rupeshk@baptisthealth.net | |
| Antoinette Pimentel | Contact | 17865962000 | antoinette.pimentel@baptisthealth.net |
| Name | Affiliation | Role |
|---|---|---|
| Rupesh R Kotecha, M.D. | Miami Cancer Institute/Baptist Health South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health South Florida | Recruiting | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30473769 | Background | Kotecha R, Gondi V, Ahluwalia MS, Brastianos PK, Mehta MP. Recent advances in managing brain metastasis. F1000Res. 2018 Nov 9;7:F1000 Faculty Rev-1772. doi: 10.12688/f1000research.15903.1. eCollection 2018. | |
| 35465884 | Background | Kotecha R, Ahluwalia MS, Siomin V, McDermott MW. Surgery, Stereotactic Radiosurgery, and Systemic Therapy in the Management of Operable Brain Metastasis. Neurol Clin. 2022 May;40(2):421-436. doi: 10.1016/j.ncl.2021.11.002. Epub 2022 Mar 31. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
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| 1 year |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |