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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Procedure: Diffusion Weighted Imaging
* Drug: Gadolinium
* Other: Laboratory Biomarker Analysis
* Procedure: Magnetic Resonance Imaging
* Procedure: Magnetic Resonance Imaging
* Procedure: Magnetic Resonance Imaging
* Procedure: Perfusion Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (MRI, tumor tissue analysis)<br>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. | Procedure: Diffusion Weighted Imaging<br>* Undergo diffusion weighted MRI<br>* Other names: MR Diffusion-Weighted Imaging;Drug: Gadolinium<br>* Undergo gadolinium-enhanced MRI<br>* Other names: Gd;Other: Laboratory Biomarker Analysis<br>* Tissue genetic analysis<br>Procedure: Magnetic Resonance Imaging<br>* Undergo gadolinium-enhanced MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Magnetic Resonance Imaging<br>* Undergo 3D volumetric T1-weighted sequence<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Magnetic Resonance Imaging<br>* Undergo FLAIR sequence<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Perfusion Magnetic Resonance Imaging<br>* Undergo perfusion MRI<br>* Other names: magnetic resonance perfusion imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 |