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

NCT ID: NCT02590497

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-20

Study Completion Date

2017-10-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (MRI, tumor tissue 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.

Group Type EXPERIMENTAL

Diffusion Weighted Imaging

Intervention Type PROCEDURE

Undergo diffusion weighted MRI

Gadolinium

Intervention Type DRUG

Undergo gadolinium-enhanced MRI

Laboratory Biomarker Analysis

Intervention Type OTHER

Tissue genetic analysis

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo gadolinium-enhanced MRI

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo 3D volumetric T1-weighted sequence

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo FLAIR sequence

Perfusion Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo perfusion MRI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diffusion Weighted Imaging

Undergo diffusion weighted MRI

Intervention Type PROCEDURE

Gadolinium

Undergo gadolinium-enhanced MRI

Intervention Type DRUG

Laboratory Biomarker Analysis

Tissue genetic analysis

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo gadolinium-enhanced MRI

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo 3D volumetric T1-weighted sequence

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo FLAIR sequence

Intervention Type PROCEDURE

Perfusion Magnetic Resonance Imaging

Undergo perfusion MRI

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diffusion Weighted MRI Diffusion-Weighted Magnetic Resonance Imaging Diffusion-Weighted MR Imaging Diffusion-Weighted MRI DWI DWI MRI DWI-MRI MR Diffusion-Weighted Imaging Gd Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging magnetic resonance perfusion imaging

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pierre Giglio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre Giglio, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2015-00873

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-15019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
NCT06209567 ACTIVE_NOT_RECRUITING EARLY_PHASE1