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临床试验/NCT05100771
NCT05100771招募中不适用

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

University Hospital, Tours5 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
5
主要终点
rate of detection of a focal cerebral lesion on the brain MRI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

rate of detection of a focal cerebral lesion on the brain MRI

时间窗: 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

次要结局

  • pediatric brain MRIs interpretation with the additional quantitative brain information(Inclusion visit)
  • Clinical examination(Inclusion visit)
  • Radiologist's confidence level in detecting lesions seen on MRI without the automated quantitative data(Inclusion visit)
  • Radiologist's confidence level in detecting lesions seen on MRI with the automated quantitative data(Inclusion visit)
  • pediatric brain MRIs interpretation without the additional quantitative brain information(Inclusion visit)
  • electroencephalography(Inclusion visit)
  • Presentation of brain volumetry and T1 relaxometry in table form and map form(Inclusion visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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