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

Not Applicable

Completed

• Conditions: High Grade Brain Tumor
• Interventions: Other: peritumoral glial cell infiltration

• Registration Number: NCT01699269
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
brain tumor	peritumoral glial cell infiltration	-

Primary Outcome Measures

Name	Time	Method
DTI-MRI	at J0

Secondary Outcome Measures

Name	Time	Method
Biopsy	at J+1
count cell	at J+10
datas co-registration	at J+20

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France