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

The Ohio State University

Status: Withdrawn

Conditions: Glioblastoma

Treatments: Procedure: Perfusion Magnetic Resonance Imaging; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Drug: Gadolinium; Procedure: Diffusion Weighted Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02590497

NCI-2015-00873 (Registry Identifier)

OSU-15019

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic (MRI, tumor tissue analysis)

Experimental group

Description:

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.

Treatment:

Procedure: Diffusion Weighted Imaging

Procedure: Magnetic Resonance Imaging

Drug: Gadolinium

Procedure: Magnetic Resonance Imaging

Procedure: Perfusion Magnetic Resonance Imaging

Other: Laboratory Biomarker Analysis

Procedure: Magnetic Resonance Imaging