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
1 other identifier
observational
240
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJune 4, 2024
June 1, 2024
3 years
September 28, 2021
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
pediatric brain MRIs interpretation with the additional quantitative brain information
Inclusion visit
Clinical examination
Inclusion visit
- +2 more secondary outcomes
Study Arms (1)
Experimental group
The experimental group will be made up of patients with focal epilepsy
Interventions
Routine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Opposition of the child and/or parent to data processing
- MRI not interpretable
- Clinical and epileptic data not available or not specifying focus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU Angers
Angers, 49000, France
CHU Grenoble
Grenoble, 38000, France
CHU Montpellier
Montpellier, 34000, France
CHU Rennes
Rennes, 35000, France
Hôpital Clocheville
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baptiste Morel
CHU Tours
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2021
First Posted
October 29, 2021
Study Start
March 14, 2022
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
June 4, 2024
Record last verified: 2024-06