Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

Glioma Clinical Trial

— GMaPIC  

Official title:

Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520492
• Other study ID #: 2014-A01568-39
• Status: Completed
• Phase: N/A
• Start date: April 3, 2015
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

Device:
• noninvasive method of ICP measurements (Elios)

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Centre Jean Perrin	Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	from baseline to 1 year
Secondary	evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)		from baseline to 1 year
Secondary	evolution of ICP before and after the progression of the relapse tumor according to clinical sign		from baseline to 1 year
Secondary	Evaluate efficiency of the measurement device of ICP changes on repetitive measurement as evaluated by composite outcome measure : clinical signs, MRI and RANO criteria		from baseline to 1 year