Image Guided Therapy in the Treatment of Gliomas

August 3, 2017 updated by: NYU Langone Health

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
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.
Other: Questionnaire administration
Ancillary studies
Procedure: Quality-of-life assessment
Ancillary studies
Procedure: Diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Names:
  • Diffusion-weighted MRI
Procedure: Perfusion-weighted magnetic resonance imaging
Undergo perfusion-weighted magnetic resonance imaging
Other Names:
  • Perfusion-weighted MRI
Procedure: Functional magnetic resonance imaging
Undergo functional MRI
Other Names:
  • fMRI, functional MRI
Procedure: Magnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
Other Names:
  • 1H-nuclear MRSI, Proton MRSI
Procedure: Therapeutic conventional surgery
Undergo maximal surgical resection
Procedure: Radiation therapy treatment planning/simulation
Undergo IMRT planning
Procedure: Intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Other Names:
  • IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Twice a year, after enrollment of first 25 patients, and at study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Twice a year, after enrollment of first 25 patients, and at study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Joshua Silverman, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 21, 2010

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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