Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
High Grade Brain Tumor |
Other: peritumoral glial cell infiltration |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| brain tumor | Other: peritumoral glial cell infiltration |
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Partick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
| Principal Investigator: | Betty JEAN | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01699269 History of Changes |
| Other Study ID Numbers: | CHU-0125, 2011-A0159-40 |
| Study First Received: | September 13, 2012 |
| Last Updated: | October 1, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013