Clinical trial NCT01263821: Image Guided Therapy in the Treatment of Gliomas
Official title: Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glioma
Keywords: glioma
biologic imaging
magnetic resonance spectroscopy
magnetic resonance imaging
perfusion imaging
diffusion imaging
functional magnetic resonance imaging
radiation therapy
intensity modulated radiation therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 15
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI
timeFrame: Twice a year, after enrollment of first 25 patients, and at study completion
Secondary outcomes:
measure: Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation
timeFrame: Twice a year, after enrollment of first 25 patients, and at study completion
measure: Clinical efficacy of this biological image-guided treatment in gliomas
timeFrame: Twice a year, after enrollment of first 25 patients, and at study completion
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Silverman, MD
role: PRINCIPAL_INVESTIGATOR
References: