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

NCT02590497 | Withdrawn DMC

• 2 other identifiers: OSU-15019NCI-2015-00873
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Diagnostic (MRI, tumor tissue analysis)

EXPERIMENTAL

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.

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

Interventions

Diffusion Weighted Imaging PROCEDURE

Undergo diffusion weighted MRI

Also known as: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging

Diagnostic (MRI, tumor tissue analysis)

Gadolinium DRUG

Undergo gadolinium-enhanced MRI

Also known as: Gd

Diagnostic (MRI, tumor tissue analysis)

Laboratory Biomarker Analysis OTHER

Tissue genetic analysis

Diagnostic (MRI, tumor tissue analysis)

Magnetic Resonance Imaging PROCEDURE

Undergo gadolinium-enhanced MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (MRI, tumor tissue analysis)

Perfusion Magnetic Resonance Imaging PROCEDURE

Undergo perfusion MRI

Also known as: magnetic resonance perfusion imaging

Diagnostic (MRI, tumor tissue analysis)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will be undergoing surgery for newly-diagnosed glioblastoma
• Subtotal, gross total or biopsy patients will be eligible
• Confirmation of pathology as glioblastoma

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Related Links

• The Jamesline

MeSH Terms

Conditions

Glioblastoma

Interventions

Gadolinium; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Pierre Giglio, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2015
• First Posted: October 29, 2015
• Study Start: March 20, 2016
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01