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Image Guided Therapy in the Treatment of Gliomas

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263821
First Posted: December 21, 2010
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose

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.


Condition Intervention
Glioma Procedure: Diffusion-weighted magnetic resonance imaging Procedure: Perfusion-weighted magnetic resonance imaging Procedure: Functional magnetic resonance imaging Procedure: Magnetic resonance spectroscopic imaging Procedure: Therapeutic conventional surgery Procedure: Quality-of-life assessment Procedure: Radiation therapy treatment planning/simulation Procedure: Intensity-modulated radiation therapy Other: Questionnaire administration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • 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 ]

Enrollment: 15
Study Start Date: August 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: Diffusion-weighted MRI
Procedure: Perfusion-weighted magnetic resonance imaging
Undergo perfusion-weighted magnetic resonance imaging
Other Name: Perfusion-weighted MRI
Procedure: Functional magnetic resonance imaging
Undergo functional MRI
Other Name: fMRI, functional MRI
Procedure: Magnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
Other Name: 1H-nuclear MRSI, Proton MRSI
Procedure: Therapeutic conventional surgery
Undergo maximal surgical resection
Procedure: Quality-of-life assessment
Ancillary studies
Procedure: Radiation therapy treatment planning/simulation
Undergo IMRT planning
Procedure: Intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Other Name: IMRT
Other: Questionnaire administration
Ancillary studies

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

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263821


Locations
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Joshua Silverman, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01263821     History of Changes
Other Study ID Numbers: 09-0069
First Submitted: December 16, 2010
First Posted: December 21, 2010
Last Update Posted: August 4, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
glioma
biologic imaging
magnetic resonance spectroscopy
magnetic resonance imaging
perfusion imaging
diffusion imaging
functional magnetic resonance imaging
radiation therapy
intensity modulated radiation therapy

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue