Image Guided Therapy in the Treatment of Gliomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas

Conditions
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Glioma

Intervention / Treatment
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* Procedure: Diffusion-weighted magnetic resonance imaging
* Procedure: Perfusion-weighted magnetic resonance imaging
* Procedure: Functional magnetic resonance imaging
* Procedure: Magnetic resonance spectroscopic imaging
* Procedure: Therapeutic conventional surgery
* Procedure: Quality-of-life assessment
* Procedure: Radiation therapy treatment planning/simulation
* Procedure: Intensity-modulated radiation therapy
* Other: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed, newly diagnosed intracranial glioma 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: Inability to obtain histological proof of glioma 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

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Procedure: Diffusion-weighted magnetic resonance imaging<br>* Undergo diffusion-weighted MRI<br>* Other names: Diffusion-weighted MRI;Procedure: Perfusion-weighted magnetic resonance imaging<br>* Undergo perfusion-weighted magnetic resonance imaging<br>* Other names: Perfusion-weighted MRI;Procedure: Functional magnetic resonance imaging<br>* Undergo functional MRI<br>* Other names: fMRI, functional MRI;Procedure: Magnetic resonance spectroscopic imaging<br>* Undergo MR spectroscopic imaging<br>* Other names: 1H-nuclear MRSI, Proton MRSI;Procedure: Therapeutic conventional surgery<br>* Undergo maximal surgical resection<br>Procedure: Quality-of-life assessment<br>* Ancillary studies<br>Procedure: Radiation therapy treatment planning/simulation<br>* Undergo IMRT planning<br>Procedure: Intensity-modulated radiation therapy<br>* Undergo intensity-modulated radiation therapy<br>* Other names: IMRT;Other: Questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Twice a year, after enrollment of first 25 patients, and at study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, biologic imaging, magnetic resonance spectroscopy, magnetic resonance imaging, perfusion imaging, diffusion imaging, functional magnetic resonance imaging, radiation therapy, intensity modulated radiation therapy