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RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain.
PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.
PRIMARY OBJECTIVES:
I. To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.
SECONDARY OBJECTIVES:
I. To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.
III. To monitor changes in neurocognitive functioning following image guided therapy.
OUTLINE: Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. After completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion-weighted magnetic resonance imaging | Procedure | Undergo diffusion-weighted MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI | Twice a year, after enrollment of first 25 patients, and at study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation | Twice a year, after enrollment of first 25 patients, and at study completion | |
| Clinical efficacy of this biological image-guided treatment in gliomas |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Silverman, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Cancer Institute | New York | New York | 10016 | United States |
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| Perfusion-weighted magnetic resonance imaging | Procedure | Undergo perfusion-weighted magnetic resonance imaging |
|
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| Functional magnetic resonance imaging | Procedure | Undergo functional MRI |
|
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| Magnetic resonance spectroscopic imaging | Procedure | Undergo MR spectroscopic imaging |
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| Therapeutic conventional surgery | Procedure | Undergo maximal surgical resection |
|
| Quality-of-life assessment | Procedure | Ancillary studies |
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| Radiation therapy treatment planning/simulation | Procedure | Undergo IMRT planning |
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| Intensity-modulated radiation therapy | Procedure | Undergo intensity-modulated radiation therapy |
|
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| Questionnaire administration | Other | Ancillary studies |
|
| Twice a year, after enrollment of first 25 patients, and at study completion |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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