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| Name | Class |
|---|---|
| Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| noninvasive method of ICP measurements | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| noninvasive method of ICP measurements (Elios) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI) | from baseline to 1 year | |
| evolution of ICP before and after the progression of the relapse tumor according to clinical sign | from baseline to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier DURANDO, MD | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38919520 | Derived | Casile M, Thivat E, Giraudet F, Ginzac A, Molnar I, Biau J, Brehant J, Lourenco B, Avan P, Durando X. Non-invasive intracranial pressure monitoring for high-grade gliomas patients treated with radiotherapy: results of the GMaPIC trial. Front Oncol. 2024 Jun 11;14:1302977. doi: 10.3389/fonc.2024.1302977. eCollection 2024. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |