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Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma (GMaPIC)

Primary Purpose

Glioma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
noninvasive method of ICP measurements (Elios)
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring intracranial pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with malignant glioma who underwent a biopsy or a partial surgery of this tumor and a radiotherapy and/or chemotherapy treatment.
  • Valid tympanometry test at least for one ear
  • Between 18 and 65 years of age
  • Cochlear response useful at least for an ear which has validate the tympanometry test
  • Written informed consent reviewed and signed by patient
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Patients who underwent a complete resection of their malignant glioma
  • Invalid tympanometry test for the both ears
  • Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test
  • Patient refusal after enlightened information

Sites / Locations

  • Centre Jean Perrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

noninvasive method of ICP measurements

Arm Description

Patients will receive a noninvasive measurement of ICP variations during each of their follow up consultation. These measurements will last until 30 minutes for the first consultation (parameters to determine) and 10 minutes for the others. A postural test will be performed during the ICP measurements when the patient condition will make it possible to do. Measurements will be performed by a device with noninvasive acoustic probes placed in the ear, and in case of electrophysiological test, regular electrodes on the brow.

Outcomes

Primary Outcome Measures

Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure)
Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure ) : clinical signs, MRI and response assessment in neuro-oncology criteria (RANO) .

Secondary Outcome Measures

evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)
evolution of ICP before and after the progression of the relapse tumor according to clinical sign
Evaluate efficiency of the measurement device of ICP changes on repetitive measurement as evaluated by composite outcome measure : clinical signs, MRI and RANO criteria

Full Information

First Posted
February 24, 2015
Last Updated
January 30, 2020
Sponsor
Centre Jean Perrin
Collaborators
Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)
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1. Study Identification

Unique Protocol Identification Number
NCT02520492
Brief Title
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
Acronym
GMaPIC
Official Title
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2015 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
Collaborators
Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost. A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds. A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination of causes: the inflammatory reaction around the tumor, the mass effect of the tumor, secondary vascular changes, a change in the flow of CSF. The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the monitoring of intracranial tumors. It is then detected by using routine clinical signs, in combination with a standard imaging method (MRI), but still subjective. The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate whether the increase in ICP precedes tumor clinical worsening and / or imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
intracranial pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
noninvasive method of ICP measurements
Arm Type
Experimental
Arm Description
Patients will receive a noninvasive measurement of ICP variations during each of their follow up consultation. These measurements will last until 30 minutes for the first consultation (parameters to determine) and 10 minutes for the others. A postural test will be performed during the ICP measurements when the patient condition will make it possible to do. Measurements will be performed by a device with noninvasive acoustic probes placed in the ear, and in case of electrophysiological test, regular electrodes on the brow.
Intervention Type
Device
Intervention Name(s)
noninvasive method of ICP measurements (Elios)
Other Intervention Name(s)
Elios device from ECHODIA company
Primary Outcome Measure Information:
Title
Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure)
Description
Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure ) : clinical signs, MRI and response assessment in neuro-oncology criteria (RANO) .
Time Frame
from baseline to 1 year
Secondary Outcome Measure Information:
Title
evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)
Time Frame
from baseline to 1 year
Title
evolution of ICP before and after the progression of the relapse tumor according to clinical sign
Time Frame
from baseline to 1 year
Title
Evaluate efficiency of the measurement device of ICP changes on repetitive measurement as evaluated by composite outcome measure : clinical signs, MRI and RANO criteria
Time Frame
from baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with malignant glioma who underwent a biopsy or a partial surgery of this tumor and a radiotherapy and/or chemotherapy treatment. Valid tympanometry test at least for one ear Between 18 and 65 years of age Cochlear response useful at least for an ear which has validate the tympanometry test Written informed consent reviewed and signed by patient Affiliation to a social security scheme Exclusion Criteria: Patients who underwent a complete resection of their malignant glioma Invalid tympanometry test for the both ears Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test Patient refusal after enlightened information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France

12. IPD Sharing Statement

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Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

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