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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02590497
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ohio State University Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pierre Giglio, MD
Principal Investigator Affiliation Ohio State University Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Withdrawn
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

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

Procedure: - Magnetic Resonance Imaging

Undergo 3D volumetric T1-weighted sequence

Procedure: - Magnetic Resonance Imaging

Undergo FLAIR sequence

Procedure: - Perfusion Magnetic Resonance Imaging

Undergo perfusion MRI

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.