Completed

TeDi-C2Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method

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What is being tested

peritumoral glial cell infiltration

Other
Who is being recruted

Brain Diseases+12

+ Central Nervous System Diseases

+ Neoplasms

From 18 to 85 Years
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: July 8, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01699269
Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: July 8, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialBrain NeoplasmsGlioma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHU Clermont-Ferrand

Clermont-Ferrand, FranceOpen CHU Clermont-Ferrand in Google Maps
CompletedOne Study Center