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Image Guided Therapy in the Treatment of Gliomas

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ClinicalTrials.gov Identifier: NCT01263821
Recruitment Status : Terminated (Lack of enrollment)
First Posted : December 21, 2010
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE December 16, 2010
First Posted Date  ICMJE December 21, 2010
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Image Guided Therapy in the Treatment of Gliomas
Official Title  ICMJE Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glioma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 8, 2014)
15
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2010)
100
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01263821
Other Study ID Numbers  ICMJE 09-0069
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua Silverman, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP