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| Name | Class |
|---|---|
| The Foundation for Barnes-Jewish Hospital | OTHER |
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Neurocognitive decline after radiation therapy is one of the most concerning complication for brain tumor patients and neuro-oncologists. There are increasing technological advances in evaluating the brain's neural connections responsible for the neurocognitive processes. For example, resting-state functional MRI (RS-fMRI) is an advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain (also referred to as resting state networks (RSNs) without requiring specific tasks by the imaged participants. Although there is evidence that shows that avoidance of specific neural networks during radiation therapy planning can lead to improved preservation of neurocognitive function afterward, it is important to first identify the most vulnerable and clinically relevant RSNs that correspond to cognitive decline. In this study, the investigators will prospectively perform RS-fMRI and neurocognitive evaluation using the NIH Toolbox Cognitive Battery (NIHTB-CB) on patients with gliomas before and after radiation therapy to generate preliminary data on what RSNs are most vulnerable to radiation injury leading to cognitive decline. A benign brain tumor cohort will also be followed to serve as control. The investigators will also evaluate the feasibility of incorporating RS-fMRI with radiation planning software for treatment optimization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDH-mutant astrocytoma or oligodendroglioma | After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed. |
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| IDH-wildtype astrocytoma | After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed. |
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| Benign Brain Tumor | After enrollment and before beginning standard of care radiation therapy (RT), MRI will be obtained for RT planning as per standard of care (SOC), and the RS-fMRI sequences will be performed at the same time. At approximately 6 months, 2 years, 5 years, and 10 years from the completion of RT, RS-fMRIs will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS-fMRI | Device | Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in neurocognitive scores as measured by NIH Toolbox cognitive battery tests | -The National Institutes of Health (NIH) has developed the National Institutes of Health Toolbox for the Assessment of Neurological and Behavior Function (NIHTB), which is a validated, normed, and multidimensional set of brief measures to assess cognitive, emotional, motor, and sensory function. The NIHTB cognitive battery (NIHTB-CB) consists of 10 tasks and can be administered in 40 min. The scores can be evaluated separately, or they can be combined into composite scores: crystallized cognition composite (reflecting the ability to access information from long-term memory and general knowledge), fluid cognition composite (reflecting the processing ability to adapt to novel environment and solve problems), and overall cognitive function composite (a combination of both crystallized and fluid scores). | Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, 2 years after completion of radiation therapy, 5 years after completion of radiation therapy, and 10 years after completion (estimated to be 10 years and 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient reported outcomes as measured by the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | -The MDASI-BT is one of the most commonly used brain-specific patient-reported questionnaires on symptom burden and has been validated extensively in the adult glioma population. It can be completed in 5 minutes and allows self-reporting of symptom severity and interference with daily activities. 22 questions asking how severe are the symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions asking how the symptoms have interfered with life with answers ranging from0=did not interfere to 10=interfered completely. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen at Siteman Cancer Center at Washington University School of Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Jiayi Huang, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| 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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| Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, 2 years after completion of radiation therapy, 5 years after completion of radiation therapy, and 10 years after completion (estimated to be 10 years and 2 months) |
| Change in quality of life as measured by the Linear Analog Scale Assessment (LASA) | -Linear Analog Scale Assessment (LASA) is a single-item questionnaire that asks the patients to rate their overall quality of life (QOL). The LASA scale runs from 0 (as bad as it can be) to 10 (as good as it can be). | Prior to initiation of radiation therapy, 6 months after completion of radiation therapy, 2 years after completion of radiation therapy, 5 years after completion of radiation therapy, and 10 years after completion (estimated to be 10 years and 2 months) |
| Tumor progression | Through completion of follow-up (estimated to be 10 years and 2 months) |
| Overall survival | Through completion of follow-up (estimated to be 10 years and 2 months) |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |