Clinical trial NCT02520492: Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
Official title: Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioma
Keywords: intracranial pressure
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)
First posted: 2015-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
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)
timeFrame: from baseline to 1 year
Secondary outcomes:
measure: evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)
timeFrame: from baseline to 1 year
measure: evolution of ICP before and after the progression of the relapse tumor according to clinical sign
timeFrame: from baseline to 1 year
measure: Evaluate efficiency of the measurement device of ICP changes on repetitive measurement as evaluated by composite outcome measure : clinical signs, MRI and RANO criteria
timeFrame: from baseline to 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, MD
role: PRINCIPAL_INVESTIGATOR
References: