About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Opposition of the child and/or parent to data processing
MRI not interpretable
Clinical and epileptic data not available or not specifying focus
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Pediatric brain MRI
Other interventionRoutine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
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
Sponsors and contacts
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