Image Guided Therapy in the Treatment of Gliomas

NYU Langone Health

Status: Terminated

Conditions: Glioma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01263821

09-0069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Procedure: Functional magnetic resonance imaging

Procedure: Intensity-modulated radiation therapy

Procedure: Magnetic resonance spectroscopic imaging

Procedure: Diffusion-weighted magnetic resonance imaging

Other: Questionnaire administration

Procedure: Therapeutic conventional surgery

Procedure: Radiation therapy treatment planning/simulation

Procedure: Quality-of-life assessment

Procedure: Perfusion-weighted magnetic resonance imaging