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Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging

Study Purpose

This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.

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 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with high grade brain tumor.
  • - Age greater than 18 yo and under 85 yo.
  • - Signed informed consent from patient.

Exclusion Criteria:

  • - -Any person with pacemaker, metal implant, claustrophobia, or any other contraindication for MR examination.
  • - Severe renal failure.
- Brain tumor biopsy contraindication

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.

NCT01699269
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.

University Hospital, Clermont-Ferrand
Principal Investigator

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

Betty JEAN
Principal Investigator Affiliation University Hospital, Clermont-Ferrand
Agency Class

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

Other
Overall Status Completed
Countries France
Conditions

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

High Grade Brain Tumor
Additional Details

Patients with high grade brain tumor undergo a usual brain tumor MRI protocol as well as a 20 or 60 directions DT-MRI sequence upon patient collaboration. Images are acquired using a 3 Tesla MRI scanner (GE MR750 Discovery). The usual brain tumor MRI protocol contains the following sequences: 3DT1, Axial T2, Flair, T2 EG, diffusion (b0-b1000), 3DT1CE. They will then undergo stereotactic tumor biopsies with Leksell frame mounted. Biopsy targets will be surgically planned. The coordinates of this first biopsy will be recorded for later coregistration with DT-MRI datasets. Histopathologic analysis of the biopsies will be done using usual procedure. various immunologic markers such as MAP2, Ki67 will be used on the first biopsy sample in order to estimate the percentage of infiltration (ratio of tumor cells number over total cells number). Analysis of DT-MRI datasets will be done using home-made software for high order tensor resolution and GA estimation at the exact coordinates of the biopsy sites. Finally a statistical analysis (Pearson or Spearman) will be done to correlate GA and the infiltration percentage.

Arms & Interventions

Arms

Other: brain tumor

Interventions

Other: - peritumoral glial cell infiltration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Clermont-Ferrand, Clermont-Ferrand, France

Status

Address

CHU Clermont-Ferrand

Clermont-Ferrand, , 63003