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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02590497
• Other study ID #: OSU-15019
• Secondary ID: NCI-2015-00873
• Status: Withdrawn
• Phase: N/A
• First received: September 20, 2015
• Last updated: January 30, 2018
• Start date: March 20, 2016
• Est. completion date: October 26, 2017

Study information

• Verified date: January 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Procedure:
• Diffusion Weighted Imaging
Undergo diffusion weighted MRI

Drug:
• Gadolinium
Undergo gadolinium-enhanced MRI

Other:
• Laboratory Biomarker Analysis
Tissue genetic analysis

Procedure:
• Magnetic Resonance Imaging
Undergo gadolinium-enhanced MRI
• Magnetic Resonance Imaging
Undergo 3D volumetric T1-weighted sequence
• Magnetic Resonance Imaging
Undergo FLAIR sequence
• Perfusion Magnetic Resonance Imaging
Undergo perfusion MRI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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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