Image Guided Therapy in the Treatment of Gliomas

Not Applicable

Terminated

• Conditions: Glioma
• Interventions: 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

• Registration Number: NCT01263821
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-21
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Functional magnetic resonance imaging	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.
Arm I	Questionnaire administration	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.
Arm I	Perfusion-weighted magnetic resonance imaging	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.
Arm I	Therapeutic conventional surgery	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.
Arm I	Quality-of-life assessment	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.
Arm I	Magnetic resonance spectroscopic imaging	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.
Arm I	Radiation therapy treatment planning/simulation	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.
Arm I	Diffusion-weighted magnetic resonance imaging	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.
Arm I	Intensity-modulated radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical efficacy of this biological image-guided treatment in gliomas	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	Twice a year, after enrollment of first 25 patients, and at study completion

Trial Locations

Locations (1)

NYU Cancer Institute; 🇺🇸 New York, New York, United States