Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2009-08-31
2014-04-30
Brief Summary
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PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm I
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.
Diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Perfusion-weighted magnetic resonance imaging
Undergo perfusion-weighted magnetic resonance imaging
Functional magnetic resonance imaging
Undergo functional MRI
Magnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
Therapeutic conventional surgery
Undergo maximal surgical resection
Quality-of-life assessment
Ancillary studies
Radiation therapy treatment planning/simulation
Undergo IMRT planning
Intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Questionnaire administration
Ancillary studies
Interventions
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Diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Perfusion-weighted magnetic resonance imaging
Undergo perfusion-weighted magnetic resonance imaging
Functional magnetic resonance imaging
Undergo functional MRI
Magnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
Therapeutic conventional surgery
Undergo maximal surgical resection
Quality-of-life assessment
Ancillary studies
Radiation therapy treatment planning/simulation
Undergo IMRT planning
Intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
* Karnofsky performance status \>= 60
* Ability to undergo MR imaging with the use of Gadolinium dye
* Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative
Exclusion Criteria
* Allergy to Gadolinium contrast
* Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
* Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
* Karnofsky performance status of =\< 50
* Prior history of radiation therapy to the brain
* Pregnancy
7 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Joshua Silverman, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Cancer Institute
New York, New York, United States
Countries
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Other Identifiers
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09-0069
Identifier Type: -
Identifier Source: org_study_id
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