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Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors

Primary Purpose

Brain and Central Nervous System Tumors

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
conventional surgery
magnetic resonance imaging
magnetic resonance spectroscopic imaging
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Newly diagnosed brain tumor Neuroradiological and clinical evidence of probable glioma Lesion in close proximity to language and motor areas No prior resection PATIENT CHARACTERISTICS: Age: 18 to 55 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other medical or psychiatric disorder No contraindications to MRI scanning (e.g., metal implants, dental prostheses other than fillings, contrast allergies) PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2000
    Last Updated
    October 2, 2012
    Sponsor
    Jonsson Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005083
    Brief Title
    Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors
    Official Title
    Defining Functional Tissue in Brain Tumors With Integrated Neuroimaging (Pilot Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no participants enrolled
    Study Start Date
    March 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Jonsson Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: New imaging procedures, such as functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging, may improve the ability to detect the extent of cancer in the brain. PURPOSE: Phase II trial to study the effectiveness of functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly diagnosed brain tumors.
    Detailed Description
    OBJECTIVES: I. Determine the definable topospecific relationship between functional neuroactivation measured by functional magnetic resonance imaging (fMRI) and chemostructural tissue measurements made with 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI) in patients with newly diagnosed brain tumors situated in the vicinity of the brain's language and motor regions. II. Determine if clinical improvement correlates with stronger imaging signatures of neuroactivation on fMRI in this patient population. III. Determine if functional loss during tumor recurrence or progression correlates with increases in choline and decreases in N-acetylaspartate on 1H-NMRSI in regions that previously displayed activation on fMRI or in associated underlying white matter regions in these patients. OUTLINE: Patients undergo preoperative functional magnetic resonance imaging (fMRI), 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), and conventional contrast MRI over 2 hours followed by neurofunctional motor and/or language neurofunctional testing. Intraoperatively, patients undergo corticography consisting of awake language mapping and motor cortex stimulation. Patients undergo repeat imaging and neurofunctional evaluation at 2 weeks following surgery and prior to any radiotherapy or chemotherapy. Patients also undergo neurological and neuropsychological testing consisting of basic gait, motor coordination, reflexes, hand motor, tongue motor, and language evaluation to measure baseline, preoperative, and postoperative clinical status and outcomes. Patients are followed every 4 months for 1 year. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 4 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain and Central Nervous System Tumors
    Keywords
    adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    magnetic resonance imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    magnetic resonance spectroscopic imaging

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Newly diagnosed brain tumor Neuroradiological and clinical evidence of probable glioma Lesion in close proximity to language and motor areas No prior resection PATIENT CHARACTERISTICS: Age: 18 to 55 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other medical or psychiatric disorder No contraindications to MRI scanning (e.g., metal implants, dental prostheses other than fillings, contrast allergies) PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffry Alger, PhD
    Organizational Affiliation
    Jonsson Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors

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