Glial Tumors Electromagnetic Signature Study by MagnetoEn... | NCT02077504

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

NCT02077504

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

May 9, 2018Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Cerebral Primitive Tumor With Chirurgical Indication

Interventions

MEG and MRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jan 5, 2018Actual

Completion Date

Jan 5, 2018Actual

First Submitted Date

Sep 18, 2013

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2018

Last Update Posted Date

May 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CONDUCTOME	Experimental	MEG and MRI	Other: MEG and MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MEG and MRI	Other	CONDUCTOME	CONDUCTOME

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François BERGER, MD, PhD	University Grenoble Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CLINATEC		Grenoble		38000	France

Intervention Browse Module

MeSH Terms

ID	Term
D015225	Magnetoencephalography
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D003943	Diagnostic Techniques, Neurological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004568	Electrodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided