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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00873 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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PI made decision
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (MRI, tumor tissue analysis) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Weighted Imaging | Procedure | Undergo diffusion weighted MRI |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Giglio, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Gadolinium | Drug | Undergo gadolinium-enhanced MRI |
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| Laboratory Biomarker Analysis | Other | Tissue genetic analysis |
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| Magnetic Resonance Imaging | Procedure | Undergo gadolinium-enhanced MRI |
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| Magnetic Resonance Imaging | Procedure | Undergo 3D volumetric T1-weighted sequence |
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| Magnetic Resonance Imaging | Procedure | Undergo FLAIR sequence |
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| Perfusion Magnetic Resonance Imaging | Procedure | Undergo perfusion MRI |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D005682 | Gadolinium |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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