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NCT Number: NCT01699269

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

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.

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Key information

Conditions

High Grade Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peritumoral glial cell infiltration

Other

Primary outcomes

  1. DTI-MRI

    Time frame: at J0

Secondary outcomes

  1. Biopsy

    Time frame: at J+1

  2. count cell

    Time frame: at J+10

  3. datas co-registration

    Time frame: at J+20

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method

Acronym: TeDi-C2

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 3, 2012
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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