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Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas


N/A
7 Years
N/A
Open (Enrolling)
Both
Glioma

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Trial Information

Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI

Outcome Time Frame:

Twice a year, after enrollment of first 25 patients, and at study completion

Safety Issue:

No

Principal Investigator

Joshua Silverman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

09-0069

NCT ID:

NCT01263821

Start Date:

August 2009

Completion Date:

December 2014

Related Keywords:

  • Glioma
  • glioma
  • biologic imaging
  • magnetic resonance spectroscopy
  • magnetic resonance imaging
  • perfusion imaging
  • diffusion imaging
  • functional magnetic resonance imaging
  • radiation therapy
  • intensity modulated radiation therapy
  • Glioma

Name

Location
NYU Cancer Institute New York, New York  10016