Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy

Focal Epilepsy Clinical Trial

— ORACLE  

Official title:

Volumétrie Optimisée en Radiologie : intérêt en IRM Cérébrale pédiatrique Dans l'Exploration de l'épilepsie Focale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100771
• Other study ID #: DR210107
• Status: Recruiting
• Start date: March 14, 2022
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: University Hospital, Tours
• Contact: Baptiste Morel
• Phone: 02 47 47 47 58
• Email: baptiste.morel[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Intervention

Other:
• Pediatric brain MRI
Routine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Grenoble	Grenoble
France	CHU Montpellier	Montpellier
France	CHU Rennes	Rennes
France	Hôpital Clocheville	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inclusion visit
Secondary	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	Inclusion visit
Secondary	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	Inclusion visit
Secondary	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	Inclusion visit
Secondary	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	Inclusion visit
Secondary	Clinical examination	Assessed by weight in kgs and height in cm, International League against epilepsy ( ILAE) classification	Inclusion visit
Secondary	electroencephalography	Assessed by focal abnormalities and area	Inclusion visit
Secondary	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	Inclusion visit