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

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.

Study Overview

• Status: Recruiting
• Conditions: Focal Epilepsy
• Intervention / Treatment: Other: Pediatric brain MRI

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Baptiste Morel; Phone Number: 02 47 47 47 58; Email: baptiste.morel@univ-tours.fr

Study Locations

• France
  • Angers, France, 49000
    • Not yet recruiting
    • CHU Angers
    • Contact: Louis Marie LEIBER; Phone Number: 02 41 35 36 37; Email: lm.leiber@gmail.com
    • Principal Investigator: Louis Marie LEIBER
  • Grenoble, France, 38000
    • Not yet recruiting
    • CHU Grenoble
    • Contact: Chantal DURAND; Phone Number: 04 76 76 75 75; Email: cdurand@chu-grenoble.fr
    • Principal Investigator: Chantal DURAND
  • Montpellier, France, 34000
    • Not yet recruiting
    • Chu Montpellier
    • Contact: Nicolas LEBOUCQ; Phone Number: 04 67 33 67 33; Email: n-leboucq@chu-montpellier.fr
    • Principal Investigator: Nicolas LEBOUCQ
  • Rennes, France, 35000
    • Not yet recruiting
    • Chu Rennes
    • Contact: Bertrand BRUNEAU; Phone Number: 02 99 28 43 21; Email: bertrand.bruneau@chu-rennes.fr
    • Principal Investigator: Bertrand BRUNEAU
  • Tours, France, 37044
    • Recruiting
    • Hôpital Clocheville
    • Contact: Baptiste Morel; Phone Number: 02 47 47 47 58; Email: baptiste.morel@univ-tours.fr
    • Principal Investigator: Baptiste Morel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; The experimental group will be made up of patients with focal epilepsy	Other: Pediatric brain MRI; Routine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Clinical examination	Assessed by weight in kgs and height in cm, International League against epilepsy ( ILAE) classification	Inclusion visit
electroencephalography	Assessed by focal abnormalities and area	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	Inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Baptiste Morel, CHU Tours

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Radiology; Brain MRI; Pediatry
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: DR210107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No