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

Not Applicable

Withdrawn

• Conditions: Glioblastoma
• Interventions: Procedure: Diffusion Weighted Imaging; Drug: Gadolinium; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Perfusion Magnetic Resonance Imaging

• Registration Number: NCT02590497
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Study Start: 2016-03-20
• Primary Completion: 2017-10-26
• Study Completion: 2017-10-26
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRI, tumor tissue analysis)	Diffusion Weighted Imaging	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.
Diagnostic (MRI, tumor tissue analysis)	Laboratory Biomarker 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.
Diagnostic (MRI, tumor tissue analysis)	Magnetic Resonance Imaging	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.
Diagnostic (MRI, tumor tissue analysis)	Perfusion Magnetic Resonance Imaging	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.
Diagnostic (MRI, tumor tissue analysis)	Gadolinium	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.

Primary Outcome Measures

Name	Time	Method
Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis	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	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	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.