Clinical trial NCT05100771: Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy
Official title: Volumétrie Optimisée en Radiologie : intérêt en IRM Cérébrale pédiatrique Dans l'Exploration de l'épilepsie Focale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focal Epilepsy
Keywords: Brain MRI
Radiology
Pediatry
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Opposition of the child and/or parent to data processing
* MRI not interpretable
* Clinical and epileptic data not available or not specifying focus

Primary outcomes:
measure: rate of detection of a focal cerebral lesion on the brain MRI
timeFrame: Inclusion visit
Secondary outcomes:
measure: Radiologist's confidence level in detecting lesions seen on MRI without the automated quantitative data
timeFrame: Inclusion visit
measure: Radiologist's confidence level in detecting lesions seen on MRI with the automated quantitative data
timeFrame: Inclusion visit
measure: pediatric brain MRIs interpretation without the additional quantitative brain information
timeFrame: Inclusion visit
measure: pediatric brain MRIs interpretation with the additional quantitative brain information
timeFrame: Inclusion visit
measure: Clinical examination
timeFrame: Inclusion visit
measure: electroencephalography
timeFrame: Inclusion visit
measure: Presentation of brain volumetry and T1 relaxometry in table form and map form
timeFrame: Inclusion visit
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Grenoble
country: France
facility: CHU Grenoble
city: Montpellier
country: France
facility: CHU Montpellier
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: Hôpital Clocheville
Study officials:
affiliation: CHU Tours
name: Baptiste Morel
role: PRINCIPAL_INVESTIGATOR
References: