GliomaGMaPICNCT02520492
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
A study testing noninvasive method of ICP measurements (Elios) in people with Glioma, run by Centre Jean Perrin at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioma
- What is being tested?
- noninvasive method of ICP measurements (Elios)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2015to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Glioma
- Being tested
- noninvasive method of ICP measurements (Elios)
- Keywords
- intracranial pressure
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive method of ICP measurements (Elios)Device
Also called Elios device from ECHODIA company
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: noninvasive method of ICP measurements (Elios) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: from baseline to 1 year
Secondary outcomes (3)
evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)
Measured: from baseline to 1 year
evolution of ICP before and after the progression of the relapse tumor according to clinical sign
Measured: from baseline to 1 year
Evaluate efficiency of the measurement device of ICP changes on repetitive measurement as evaluated by composite outcome measure : clinical signs, MRI and RANO criteria
Measured: from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start3 Apr 2015
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520492
- Sponsor's protocol ID
- 2014-A01568-39
- Acronym
- GMaPIC
- Status last verified
- Jan 2020
- First submitted
- 24 Feb 2015
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38919520
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
- ClinicalTrials.gov ID
- NCT02520492
- Acronym / sponsor ID
- GMaPIC / 2014-A01568-39
- Conditions
- Glioma
- Keywords
- intracranial pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| noninvasive method of ICP measurements | Experimental | Device: noninvasive method of ICP measurements (Elios)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noninvasive method of ICP measurements (Elios)Also: Elios device from ECHODIA company | Device | noninvasive method of ICP measurements |
Primary outcome
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)
Time frame: from baseline to 1 year
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) .
3 secondary outcomes
evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)
Time frame: from baseline to 1 year
evolution of ICP before and after the progression of the relapse tumor according to clinical sign
Time frame: from baseline to 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 38919520Casile 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier DURANDO, MD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive method of ICP measurements (Elios) in people with Glioma, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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) (time frame: from baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02520492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.