Image Guided Therapy in the Treatment of Gliomas

NYU Langone Health15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Glioma

Interventions

Diffusion-weighted magnetic resonance imagingPROCEDURE

Undergo diffusion-weighted MRI

Perfusion-weighted magnetic resonance imagingPROCEDURE

Undergo perfusion-weighted magnetic resonance imaging

Functional magnetic resonance imagingPROCEDURE

Undergo functional MRI

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Cancer Institute

New York, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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