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Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery

Primary Purpose

Glioblastoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diffusion Weighted Imaging
Gadolinium
Laboratory Biomarker Analysis
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Perfusion Magnetic Resonance Imaging
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who will be undergoing surgery for newly-diagnosed glioblastoma
  • Subtotal, gross total or biopsy patients will be eligible
  • Confirmation of pathology as glioblastoma

Exclusion Criteria:

  • Tissue analysis demonstrating pathology other than glioblastoma
  • Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (MRI, tumor tissue analysis)

    Arm Description

    Patients undergo MRI before and after gadolinium contrast administration, including 3D volumetric T1-weighted sequence, FLAIR sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.

    Outcomes

    Primary Outcome Measures

    Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
    The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in OSU and 1.5 T in MUSC) will be explored in each class of patients.
    Diffusional kurtosis (DK) values
    The average DK parameter and cerebral blood volume (CBV) parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in Ohio State University [OSU] and 1.5 T in Medical University of South Carolina [MUSC]) will be explored in each class of patients.
    Genetic tumor profile
    The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2015
    Last Updated
    January 30, 2018
    Sponsor
    Ohio State University Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02590497
    Brief Title
    Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery
    Official Title
    The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI made decision
    Study Start Date
    March 20, 2016 (Actual)
    Primary Completion Date
    October 26, 2017 (Actual)
    Study Completion Date
    October 26, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University Comprehensive Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Imaging, using magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. If MRI can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.
    Detailed Description
    PRIMARY OBJECTIVES: I. Determine the correlation between the genetic and neuroimaging signature of glioblastoma. II. Determine the correlation between the neuroimaging signature of glioblastoma and prognosis. OUTLINE: Patients undergo MRI before and after gadolinium contrast administration, including 3-dimensional (3D) volumetric T1-weighted sequence, fluid attenuated inversion recovery (FLAIR) sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (MRI, tumor tissue analysis)
    Arm Type
    Experimental
    Arm Description
    Patients undergo MRI before and after gadolinium contrast administration, including 3D volumetric T1-weighted sequence, FLAIR sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.
    Intervention Type
    Procedure
    Intervention Name(s)
    Diffusion Weighted Imaging
    Other Intervention Name(s)
    Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging
    Intervention Description
    Undergo diffusion weighted MRI
    Intervention Type
    Drug
    Intervention Name(s)
    Gadolinium
    Other Intervention Name(s)
    Gd
    Intervention Description
    Undergo gadolinium-enhanced MRI
    Intervention Type
    Other
    Intervention Name(s)
    Laboratory Biomarker Analysis
    Intervention Description
    Tissue genetic analysis
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic Resonance Imaging
    Other Intervention Name(s)
    Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
    Intervention Description
    Undergo gadolinium-enhanced MRI
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic Resonance Imaging
    Other Intervention Name(s)
    Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
    Intervention Description
    Undergo 3D volumetric T1-weighted sequence
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic Resonance Imaging
    Other Intervention Name(s)
    Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
    Intervention Description
    Undergo FLAIR sequence
    Intervention Type
    Procedure
    Intervention Name(s)
    Perfusion Magnetic Resonance Imaging
    Other Intervention Name(s)
    magnetic resonance perfusion imaging
    Intervention Description
    Undergo perfusion MRI
    Primary Outcome Measure Information:
    Title
    Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
    Description
    The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in OSU and 1.5 T in MUSC) will be explored in each class of patients.
    Time Frame
    Day 1
    Title
    Diffusional kurtosis (DK) values
    Description
    The average DK parameter and cerebral blood volume (CBV) parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in Ohio State University [OSU] and 1.5 T in Medical University of South Carolina [MUSC]) will be explored in each class of patients.
    Time Frame
    Day 1
    Title
    Genetic tumor profile
    Description
    The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who will be undergoing surgery for newly-diagnosed glioblastoma Subtotal, gross total or biopsy patients will be eligible Confirmation of pathology as glioblastoma Exclusion Criteria: Tissue analysis demonstrating pathology other than glioblastoma Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre Giglio, MD
    Organizational Affiliation
    Ohio State University Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://cancer.osu.edu
    Description
    The Jamesline

    Learn more about this trial

    Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery

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