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

Ohio State University Comprehensive Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Glioblastoma

Interventions

Diffusion Weighted ImagingPROCEDURE

Undergo diffusion weighted MRI

GadoliniumDRUG

Undergo gadolinium-enhanced MRI

Laboratory Biomarker AnalysisOTHER

Tissue genetic analysis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 1

Genetic tumor profile

Time frame: Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.