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Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)

Primary Purpose

High Grade Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
peritumoral glial cell infiltration
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for High Grade Brain Tumor focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

brain tumor

Arm Description

Outcomes

Primary Outcome Measures

DTI-MRI

Secondary Outcome Measures

Biopsy
count cell
datas co-registration

Full Information

First Posted
September 13, 2012
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01699269
Brief Title
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging
Acronym
TeDi-C2
Official Title
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
brain tumor
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
peritumoral glial cell infiltration
Primary Outcome Measure Information:
Title
DTI-MRI
Time Frame
at J0
Secondary Outcome Measure Information:
Title
Biopsy
Time Frame
at J+1
Title
count cell
Time Frame
at J+10
Title
datas co-registration
Time Frame
at J+20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty JEAN
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging

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