An interventional study of peritumoral glial cell infiltration in High Grade Brain Tumor, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Screening
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.
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand