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Image Guided Therapy in the Treatment of Gliomas

Primary Purpose

Glioma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diffusion-weighted magnetic resonance imaging
Perfusion-weighted magnetic resonance imaging
Functional magnetic resonance imaging
Magnetic resonance spectroscopic imaging
Therapeutic conventional surgery
Quality-of-life assessment
Radiation therapy treatment planning/simulation
Intensity-modulated radiation therapy
Questionnaire administration
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring glioma, biologic imaging, magnetic resonance spectroscopy, magnetic resonance imaging, perfusion imaging, diffusion imaging, functional magnetic resonance imaging, radiation therapy, intensity modulated radiation therapy

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation
Clinical efficacy of this biological image-guided treatment in gliomas

Full Information

First Posted
December 16, 2010
Last Updated
August 3, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01263821
Brief Title
Image Guided Therapy in the Treatment of Gliomas
Official Title
Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
Diffusion-weighted MRI
Intervention Description
Undergo diffusion-weighted MRI
Intervention Type
Procedure
Intervention Name(s)
Perfusion-weighted magnetic resonance imaging
Other Intervention Name(s)
Perfusion-weighted MRI
Intervention Description
Undergo perfusion-weighted magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
Functional magnetic resonance imaging
Other Intervention Name(s)
fMRI, functional MRI
Intervention Description
Undergo functional MRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance spectroscopic imaging
Other Intervention Name(s)
1H-nuclear MRSI, Proton MRSI
Intervention Description
Undergo MR spectroscopic imaging
Intervention Type
Procedure
Intervention Name(s)
Therapeutic conventional surgery
Intervention Description
Undergo maximal surgical resection
Intervention Type
Procedure
Intervention Name(s)
Quality-of-life assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Radiation therapy treatment planning/simulation
Intervention Description
Undergo IMRT planning
Intervention Type
Procedure
Intervention Name(s)
Intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
Undergo intensity-modulated radiation therapy
Intervention Type
Other
Intervention Name(s)
Questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Silverman, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Image Guided Therapy in the Treatment of Gliomas

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