Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01699269|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|High Grade Brain Tumor||Other: peritumoral glial cell infiltration||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Other: peritumoral glial cell infiltration
- DTI-MRI [ Time Frame: at J0 ]
- Biopsy [ Time Frame: at J+1 ]
- count cell [ Time Frame: at J+10 ]
- datas co-registration [ Time Frame: at J+20 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699269
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Betty JEAN||University Hospital, Clermont-Ferrand|