Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME" (CONDUCTOME)

May 3, 2018 updated by: University Hospital, Grenoble

Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature

The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CLINATEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • more or equal than 18 years old
  • patient affiliated to social security or similarly regime
  • informed consent form signed
  • supra-tentorial primitive cerebral tumor

Exclusion Criteria:

  • Pregnant women and lactating mothers
  • Ward of court or under guardianship
  • Adult unable to express their consent
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
  • Person under legal protection
  • Magnetic Resonance Imaging (MRI) contraindication (implanted material non MRI-compatible, ferro-magnetic foreign body, claustrophobia)
  • Patients needed emergency medical care for other pathology
  • severely altered general health (Performance Status 3 or 4)

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CONDUCTOME
MEG and MRI
Other: MEG and MRI
CONDUCTOME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction
Time Frame: 1 week before exeresis
1 week before exeresis
anatomopathologic and clinical data in tumor grade prediction
Time Frame: 1 week after exeresis
1 week after exeresis

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of molecules involved in glial cells neuralisation expression in tumor samples
Time Frame: Up to 1 month after surgery
Up to 1 month after surgery
Tumoral growth modelisation from patient MEG and MRI data
Time Frame: Up to 1 month after surgery
Up to 1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 5, 2018

Study Completion (Actual)

January 5, 2018

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONDUCTOME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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