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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to:
Data suggests that regions of the normal brain exposed to radiation doses that has otherwise been regarded as safe and not limited by current radiation treatment planning may contribute to the risk of late neurocognitive injury. Radiation dose-dependent subclinical vascular effects have been reported in irradiated normal brain tissue and have been hypothesized to be a potential mechanism of action. Direct neuronal injury is another potential mechanism of injury. 1)Estimate the degree of cognitive loss following RT. 2) Demonstrate evidence of radiation induced subclinical vascular and neuronal injury in adjacent brain regions receiving exit doses of radiation. Subjects will include patients with malignancies of the skull of the skull base or patients with low grade glioma who require radiotherapy. Baseline MRI imaging of the brain utilizing established techniques will be used to identify and characterize the regions of interest anatomically adjacent to the regions of intended high dose irradiation. The MRI data for the ROIs will be registered with the radiotherapy treatment planning CT in order to create a single volume of data where each voxel corresponds to a vector containing the multi-parametric information. Subsequent repeat MRI imaging will be at 1.5, 4.5, 12 and 24 months following completion of the radiotherapy for patients with low grade glioma and 1.5 and 12 months post radiotherapy for patients with malignancies involving the skull base. Both cohorts will repeat standard neurocognitive evaluation at 1.5, 4.5,12 and 24 months following completion of radiotherapy. Analysis: Neurocognitive domains will be evaluated at the designated time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Subjects with a histological diagnosis of malignancy of the base of skull necessitating irradiation to a minimum of 60 Gy, ECOG PS 0-1 with no evidence of metastatic disease and an estimate life expectancy of at least 1 year and who is able to provide informed consent. Subjects will undergo standard CT simulation and radiotherapy treatment planning. |
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| Cohort 2 | Subjects with a histological diagnosis of low grade glioma requiring radiotherapy. ECOG PS 0-1 with no evidence of metastatic disease and an estimated life expectancy of at least 1 year and who is able to provide informed consent. Subjects will undergo standard CT simulation and radiotherapy treatment planning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon treatment plans | Radiation | 10 of the 30 subjects on Cohort 1 will receive photon treatment plans. |
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| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive evaluation | verbal and visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression |
| Measure | Description | Time Frame |
|---|---|---|
| Advance MRI imaging | Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing |
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Inclusion Criteria: For Cohort 1 (Patients with tumor involving the base of skull)
Inclusion Criteria: For Cohort 2 (Patients with Low Grade Gliomas)
Exclusion Criteria: for Both Cohorts
Additional Exclusion Criteria for Cohort 2 (Patients with Low Grade Gliomas)
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Eligible subjects will include patients with malignancies of the skull base or patients with low grade glioma who require radiotherapy. 10 subjects receiving photon treatment plans and 20 subjects receiving proton treatment plans with malignancies involving the base skull and a total of 40 patient with low grade glioma will be prospectively enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Alonso Basanta, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Proton Treatment Plans | Radiation | 20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull. |
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| Neurocognitive evaluation | Behavioral | Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression. |
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| Advanced MRI imaging | Device | Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing |
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| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |