The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be undergoing surgery for newly-diagnosed glioblastoma
- •Subtotal, gross total or biopsy patients will be eligible
- •Confirmation of pathology as glioblastoma
排除标准
- •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
研究组 & 干预措施
Diagnostic (MRI, tumor tissue analysis)
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.
干预措施: Diffusion Weighted Imaging (Procedure)
Diagnostic (MRI, tumor tissue analysis)
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.
干预措施: Gadolinium (Drug)
Diagnostic (MRI, tumor tissue analysis)
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.
干预措施: Laboratory Biomarker Analysis (Other)
Diagnostic (MRI, tumor tissue analysis)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (MRI, tumor tissue analysis)
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.
干预措施: Perfusion Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
时间窗: Day 1
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
时间窗: Day 1
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
时间窗: Day 1
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.
次要结局
未报告次要终点
研究者
Pierre Giglio
Principal Investigator
Ohio State University Comprehensive Cancer Center