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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorUniversity Hospital, Tours

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pediatric brain MRI

    Other intervention

    Routine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: Experimental group1 intervention

Trial outcomes

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

Time frame
Inclusion visit

Secondary outcomes

1

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

Time frame
Inclusion visit
2

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

Time frame
Inclusion visit
3

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

Time frame
Inclusion visit
4

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

Time frame
Inclusion visit

Other outcomes

Sponsors and contacts

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