Image Guided Therapy in the Treatment of Gliomas

This study has suspended participant recruitment.
(Due to administrative issues)
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01263821
First received: December 16, 2010
Last updated: October 11, 2013
Last verified: October 2013
  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
Radiation: Radiation therapy treatment planning/simulation
Radiation: Intensity-modulated radiation therapy
Other: Questionnaire administration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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
Other Name: Quality-of-life assessment
Radiation: Radiation therapy treatment planning/simulation
Undergo IMRT planning
Radiation: 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

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01263821     History of Changes
Other Study ID Numbers: 09-0069
Study First Received: December 16, 2010
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014