Image Guided Therapy in the Treatment of Gliomas
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|ClinicalTrials.gov Identifier: NCT01263821|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : December 21, 2010
Last Update Posted : August 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioma||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||Not Applicable|
I. To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: 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.
Procedure: Diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: Diffusion-weighted MRIProcedure: Perfusion-weighted magnetic resonance imaging
Undergo perfusion-weighted magnetic resonance imaging
Other Name: Perfusion-weighted MRIProcedure: Functional magnetic resonance imaging
Undergo functional MRI
Other Name: fMRI, functional MRIProcedure: Magnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
Other Name: 1H-nuclear MRSI, Proton MRSIProcedure: Therapeutic conventional surgery
Undergo maximal surgical resectionProcedure: Quality-of-life assessment
Ancillary studiesProcedure: Radiation therapy treatment planning/simulation
Undergo IMRT planningProcedure: Intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Other Name: IMRTOther: Questionnaire administration
- Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI [ Time Frame: Twice a year, after enrollment of first 25 patients, and at study completion ]
- Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation [ Time Frame: Twice a year, after enrollment of first 25 patients, and at study completion ]
- Clinical efficacy of this biological image-guided treatment in gliomas [ Time Frame: Twice a year, after enrollment of first 25 patients, and at study completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263821
|United States, New York|
|NYU Cancer Institute|
|New York, New York, United States, 10016|
|Principal Investigator:||Joshua Silverman, MD||New York University School of Medicine|