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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.
Diffusion weighted imaging (DWI) and Perfusion-weighted imaging (PWI) are validated MRI techniques that aid in diagnosis, prognosis, and assessment of treatment efficacy and, while they are utilized in select clinical settings, they have yet to make their way into routine clinical practice at most centers. DWI is a non-invasive MRI modality that has demonstrated an ability to predict for a response to radiation therapy in the primary treatment of patients with glioblastoma (GBM). PWI is one collection of measures that includes dynamic susceptibility contrast (DSC) enhancement and dynamic contrast-enhanced (DCE) imaging. The latter methods of MRI-adapted radiotherapy allow the opportunity to direct high-dose radiation to areas most likely to harbor resistant tumor while avoiding regions having a low likelihood of future recurrence. Multiple MRI sequences have been developed and validated that may identify high-risk areas in patients with High-grade glioma (HGG) and the ability to acquire multiple sequential time points creates an opportunity for dynamic radiotherapy that has not previously been explored. The current standard of care in radiotherapy does not incorporate any additional neuroimaging data.
This study hypothesizes that pre- and mid-treatment advanced imaging with (DWI) and (PWI) in patients with HGG can be used to generate an adaptive radiotherapy boost volume that correlates with areas of future recurrence and that this volume has a higher spatial correlation relative to the current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with primary high-grade glioma | Patients will receive standard of care radiotherapy over 30-33 once-daily fractions. Subjects receiving hypofractionated radiotherapy will receive radiotherapy per standard of care over 15 once-daily fractions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prediction of progression of disease in patients with high-grade glioma. | To compare the volume of the current standard of care conedown volume definition with an MRI-based adaptive plan in predicting the location of disease progression in patients with high-grade glioma. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the progression-free and overall survival in patient with high-grade glioma. | Assess the prognostic and predictive value of highly-diffusion weighted and perfusion-weighted imaging in estimating progression-free and overall survival in patients with high-grade glioma. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Residents of New York or commutable distance for treatment and follow up.
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| Name | Affiliation | Role |
|---|---|---|
| Tony J. Wang, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center/NYPH | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| 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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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |