Glioma
Conditions
Keywords
glioma, biologic imaging, magnetic resonance spectroscopy, magnetic resonance imaging, perfusion imaging, diffusion imaging, functional magnetic resonance imaging, radiation therapy, intensity modulated radiation therapy
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.
Interventions
PROCEDUREDiffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Undergo perfusion-weighted magnetic resonance imaging
PROCEDUREFunctional magnetic resonance imaging
Undergo functional MRI
PROCEDUREMagnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
PROCEDURETherapeutic conventional surgery
Undergo maximal surgical resection
PROCEDUREQuality-of-life assessment
Ancillary studies
Undergo IMRT planning
PROCEDUREIntensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
OTHERQuestionnaire administration
Ancillary studies
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed