Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
|Official Title:||Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method|
- DTI-MRI [ Time Frame: at J0 ] [ Designated as safety issue: Yes ]
- Biopsy [ Time Frame: at J+1 ] [ Designated as safety issue: Yes ]
- count cell [ Time Frame: at J+10 ] [ Designated as safety issue: Yes ]
- datas co-registration [ Time Frame: at J+20 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699269
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Betty JEAN||University Hospital, Clermont-Ferrand|