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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT, MRI | Other | In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F fluciclovine | Drug | Patients will receive a standard 5 millicuries dose 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 sensitivity for PET/CT | Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases >2 cm treated with SSRS. | through study completion, an average of 1 year |
| Change in sensitivity for MRI | To calculate the sensitivity of pre-treatment contrast-enhanced MRI. | through study completion, an average of 1 year |
| Change in the standardized uptake value (SUV) parameters | To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare change of SUV metrics of 18F-fluciclovine PET | To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake | baseline |
| Compare change of SUV metrics of contrast-enhanced MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupesh C Kotecha, MD | Contact | 17865962000 | rupeshk@baptisthealth.net | |
| Kristy Reyes | Contact | 786-524-7311 | Kristina.Reyes@baptisthealth.net |
| Name | Affiliation | Role |
|---|---|---|
| Rupesh R Kotecha, MD | Miami Cancer Institute (MCI) at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute | Recruiting | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34081125 | Derived | Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. 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. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available. |
| Label | URL |
|---|---|
| Miami Cancer Institute website | View source |
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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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This is a prospective, single-site, single-arm, phase 1 proof-of-concept study to assess the potential clinical utility of 18F-fluciclovine PET/CT as a functional integral biomarker for patients with large brain metastases (>2 cm) treated with Staged Stereotactic Radiosurgery (SSRS).
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To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).
| baseline |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |