Focal EpilepsyORACLENCT05100771
Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy
An observational study of Focal Epilepsy, run by University Hospital, Tours at 5 sites in France.
Trial summary
Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Pediatric brain MRI
- How many people
- 240 participants
- Where
- 5 sitesFrance
- Study dates
- 14 Mar 2022to Mar 2025
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All participants will be included in a visit as part of their routine follow-up with a pediatric epilepsy specialist for a work-up including clinical examination, EEG examination and assessment of symptomatology between clinical, EEG and MRI. All visits and examinations are part of routine care. Additional quantitative data from the MRI will not influence medical management in any way.
Who may be able to join
- Patient aged 1-18 years
- Referred or followed by a pediatrician for epilepsy with focal onset
- Requiring brain MRI as part of the work-up
Who cannot join
- Opposition of the child and/or parent to data processing
- MRI not interpretable
- Clinical and epileptic data not available or not specifying focus
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
CHU Angers
Angers, 49000
Louis Marie LEIBER, 02 41 35 36 37, lm.leiber@gmail.com
Louis Marie LEIBER
- Not yet recruiting
CHU Grenoble
Grenoble, 38000
Chantal DURAND, 04 76 76 75 75, cdurand@chu-grenoble.fr
Chantal DURAND
- Not yet recruiting
CHU Montpellier
Montpellier, 34000
Nicolas LEBOUCQ, 04 67 33 67 33, n-leboucq@chu-montpellier.fr
Nicolas LEBOUCQ
- Not yet recruiting
CHU Rennes
Rennes, 35000
Bertrand BRUNEAU, 02 99 28 43 21, bertrand.bruneau@chu-rennes.fr
Bertrand BRUNEAU
- Recruiting
Hôpital Clocheville
Tours, 37044
Baptiste Morel, 02 47 47 47 58, baptiste.morel@univ-tours.fr
Baptiste Morel
About this study
Official title: Volumétrie Optimisée en Radiologie : intérêt en IRM Cérébrale pédiatrique Dans l'Exploration de l'épilepsie Focale
Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.
Read the detailed description
Focal epilepsies are a very heterogeneous group comprising epilepsies of structural, genetic, metabolic, immune and infectious etiologies. In daily practice, epilepsy is considered as structural if lesions are visible on brain MRI in a location consistent with electro-clinical data. In the absence of visible lesion and clinico-biological arguments for a genetic, metabolic, immune or infectious cause, these epilepsies can be divided into two groups: self-limited focal epilepsies (formerly called idiopathic or functional), such as benign epilepsy with centrotemporal spikes (SLECTS) and secondly epilepsies of unknown causes. This classification underlines the idea that a lesion might be responsible for the epileptic disease but could be invisible due to the lack of sensitivity of our current diagnostic methods, especially in imaging.
The prevalence of patients with non lesional epilepsy defined by MRI is significantly higher in children (31%) than in adults (21%). Epileptic patients with normal conventional MRI have a lower chance of having surgery than those with lesions demonstrated by presurgical MRI and, if so, less chance of becoming seizure-free. It can be challenging to depict brain volume abnormalities in the pediatric population on MRI. The major challenge is therefore to raise sensitivity of brain imaging analysis. Voxel-based morphometric MRI post-processing in MRI-negative epilepsies can be a practical and valuable tool to aid subtle MRI abnormalities detection and confirm visually identified questionable abnormalities in patients with focal epilepsy.
In this study, we prospectively included children with suspected focal epilepsy having a brain MRI using a MP2RAGE sequence and a post-processing morphometric analysis program (MAP) allowing us to obtain automatically both brain volumetry and T1 relaxometry. The MAP has been validated with reference ranges in healthy children. Our hypothesis was that the quantitative information will improve the sensitivity of brain MRI in children with suspected focal epilepsy. The objectives were to compare the rate of detection of a focal cerebral lesion on the brain MRI carried out during the exploration of suspected focal epilepsy without then with the quantitative volumetry and T1 relaxometry obtained in the inclusion center and then by double anonymized review.
- Conditions
- Focal Epilepsy
- Being tested
- Pediatric brain MRI
- Keywords
- Brain MRI, Radiology, Pediatry
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric brain MRIOther
Routine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | The experimental group will be made up of patients with focal epilepsy Receives: Other: Pediatric brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of detection of a focal cerebral lesion on the brain MRI
carried out during the exploration of suspected focal epilepsy without then with the quantitative volumetry and T1 relaxometry obtained in the inclusion center and then by double anonymized review
Measured: Inclusion visit
Secondary outcomes (7)
Radiologist's confidence level in detecting lesions seen on MRI without the automated quantitative data
Measured by a semi-quantitative visual analogue scale in the detection of brain lesions observed on MRI
Measured: Inclusion visit
Radiologist's confidence level in detecting lesions seen on MRI with the automated quantitative data
Measured by a semi-quantitative visual analogue scale in the detection of brain lesions observed on MRI
Measured: Inclusion visit
pediatric brain MRIs interpretation without the additional quantitative brain information
Inter-observer agreement in terms of normal or not normal MRI and in case of abnormality, the type of abnormality
Measured: Inclusion visit
pediatric brain MRIs interpretation with the additional quantitative brain information
Inter-observer agreement in terms of normal or not normal MRI and in case of abnormality, the type of abnormality
Measured: Inclusion visit
Clinical examination
Assessed by weight in kgs and height in cm, International League against epilepsy ( ILAE) classification
Measured: Inclusion visit
electroencephalography
Assessed by focal abnormalities and area
Measured: Inclusion visit
Presentation of brain volumetry and T1 relaxometry in table form and map form
pourcentage of choice between the table form and the map form depending on the radiologists
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start14 Mar 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baptiste Morel, Principal investigator, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100771
- Sponsor's protocol ID
- DR210107
- Acronym
- ORACLE
- Status last verified
- Jun 2024
- First submitted
- 28 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumétrie Optimisée en Radiologie : intérêt en IRM Cérébrale pédiatrique Dans l'Exploration de l'épilepsie Focale
- ClinicalTrials.gov ID
- NCT05100771
- Acronym / sponsor ID
- ORACLE / DR210107
- Conditions
- Focal Epilepsy
- Keywords
- Brain MRI, Radiology, Pediatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Oct 2021 (actual)
- 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.
Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.
Detailed description
Focal epilepsies are a very heterogeneous group comprising epilepsies of structural, genetic, metabolic, immune and infectious etiologies. In daily practice, epilepsy is considered as structural if lesions are visible on brain MRI in a location consistent with electro-clinical data. In the absence of visible lesion and clinico-biological arguments for a genetic, metabolic, immune or infectious cause, these epilepsies can be divided into two groups: self-limited focal epilepsies (formerly called idiopathic or functional), such as benign epilepsy with centrotemporal spikes (SLECTS) and secondly epilepsies of unknown causes. This classification underlines the idea that a lesion might be responsible for the epileptic disease but could be invisible due to the lack of sensitivity of our current diagnostic methods, especially in imaging.
The prevalence of patients with non lesional epilepsy defined by MRI is significantly higher in children (31%) than in adults (21%). Epileptic patients with normal conventional MRI have a lower chance of having surgery than those with lesions demonstrated by presurgical MRI and, if so, less chance of becoming seizure-free. It can be challenging to depict brain volume abnormalities in the pediatric population on MRI. The major challenge is therefore to raise sensitivity of brain imaging analysis. Voxel-based morphometric MRI post-processing in MRI-negative epilepsies can be a practical and valuable tool to aid subtle MRI abnormalities detection and confirm visually identified questionable abnormalities in patients with focal epilepsy.
In this study, we prospectively included children with suspected focal epilepsy having a brain MRI using a MP2RAGE sequence and a post-processing morphometric analysis program (MAP) allowing us to obtain automatically both brain volumetry and T1 relaxometry. The MAP has been validated with reference ranges in healthy children. Our hypothesis was that the quantitative information will improve the sensitivity of brain MRI in children with suspected focal epilepsy. The objectives were to compare the rate of detection of a focal cerebral lesion on the brain MRI carried out during the exploration of suspected focal epilepsy without then with the quantitative volumetry and T1 relaxometry obtained in the inclusion center and then by double anonymized review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: Pediatric brain MRIThe experimental group will be made up of patients with focal epilepsy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All participants will be included in a visit as part of their routine follow-up with a pediatric epilepsy specialist for a work-up including clinical examination, EEG examination and assessment of symptomatology between clinical, EEG and MRI. All visits and examinations are part of routine care. Additional quantitative data from the MRI will not influence medical management in any way.
Key inclusion criteria (3 listed)
- Patient aged 1-18 years
- Referred or followed by a pediatrician for epilepsy with focal onset
- Requiring brain MRI as part of the work-up
Key exclusion criteria (3 listed)
- Opposition of the child and/or parent to data processing
- MRI not interpretable
- Clinical and epileptic data not available or not specifying focus
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 |
|---|---|---|
| Pediatric brain MRIRoutine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry) | Other | Experimental group |
Primary outcome
rate of detection of a focal cerebral lesion on the brain MRI
Time frame: Inclusion visit
carried out during the exploration of suspected focal epilepsy without then with the quantitative volumetry and T1 relaxometry obtained in the inclusion center and then by double anonymized review
7 secondary outcomes
Radiologist's confidence level in detecting lesions seen on MRI without the automated quantitative data
Time frame: Inclusion visit
Radiologist's confidence level in detecting lesions seen on MRI with the automated quantitative data
Time frame: Inclusion visit
pediatric brain MRIs interpretation without the additional quantitative brain information
Time frame: Inclusion visit
pediatric brain MRIs interpretation with the additional quantitative brain information
Time frame: Inclusion visit
Clinical examination
Time frame: Inclusion visit
electroencephalography
Time frame: Inclusion visit
Presentation of brain volumetry and T1 relaxometry in table form and map form
Time frame: Inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: Undecided
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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
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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.
Baptiste Morel principal investigator
CHU Tours
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Epilepsy, run by University Hospital, Tours at 5 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baptiste Morel (02 47 47 47 58, baptiste.morel@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of detection of a focal cerebral lesion on the brain MRI (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.