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

Primary Purpose

Cerebral Primitive Tumor With Chirurgical Indication

Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
MEG and MRI
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebral Primitive Tumor With Chirurgical Indication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • CLINATEC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CONDUCTOME

Arm Description

MEG and MRI

Outcomes

Primary Outcome Measures

Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction
anatomopathologic and clinical data in tumor grade prediction

Secondary Outcome Measures

Measurement of molecules involved in glial cells neuralisation expression in tumor samples
Tumoral growth modelisation from patient MEG and MRI data

Full Information

First Posted
September 18, 2013
Last Updated
May 3, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02077504
Brief Title
Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME"
Acronym
CONDUCTOME
Official Title
Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
January 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Primitive Tumor With Chirurgical Indication

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONDUCTOME
Arm Type
Experimental
Arm Description
MEG and MRI
Intervention Type
Other
Intervention Name(s)
MEG and MRI
Intervention Description
CONDUCTOME
Primary Outcome Measure Information:
Title
Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction
Time Frame
1 week before exeresis
Title
anatomopathologic and clinical data in tumor grade prediction
Time Frame
1 week after exeresis
Secondary Outcome Measure Information:
Title
Measurement of molecules involved in glial cells neuralisation expression in tumor samples
Time Frame
Up to 1 month after surgery
Title
Tumoral growth modelisation from patient MEG and MRI data
Time Frame
Up to 1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François BERGER, MD, PhD
Organizational Affiliation
University Grenoble Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CLINATEC
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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

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