Clinical trial NCT01699269: Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging
Official title: Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Grade Brain Tumor
Keywords: High grade brain tumor
Glioma
Glioblastoma Multiform
Brain Cancer
Diffusion-Weighted Magnetic Resonance Imaging
High order diffusion tensor
Imaging guided biopsy
Histopathologic evaluation
Infiltration percentage
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: DTI-MRI
timeFrame: at J0
Secondary outcomes:
measure: Biopsy
timeFrame: at J+1
measure: count cell
timeFrame: at J+10
measure: datas co-registration
timeFrame: at J+20
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Betty JEAN
role: PRINCIPAL_INVESTIGATOR
References: