Normative Brain Volume Profiles From Multicenter Fetal MRI

Not yet recruiting

• Conditions: Multiparametric Magnetic Resonnance Imaging; Cortical Development Malformation; Prenatal Diagnosis; Brain Cortical Thickness; Fetal Development

• Registration Number: NCT06081036
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Fetal brain MRI is an essential diagnostic tool to inform parents about the prognosis of abnormalities detected on routine ultrasound. Recent work has shown that brain MRI measurements at the antenatal stage are predictive of the child's postnatal development. However, this work remains limited to basic research, in part because of the lack of normative curves of brain tissue volume evolution from fetal MRI acquired in clinical routine. This project aims to fill this gap. For this purpose, the project will exploit fetal MRI scans acquired in 4 French hospitals (Marseille, Nice, Montpellier and Paris): MRI scans without abnormalities will be centralized for analysis, and families who have undergone these scans will be contacted to evaluate the development of their children after birth. Normative curves will be established by applying a set of treatments developed by the laboratory in Marseille collaborating in the project. Ultimately, these curves will help to clarify the diagnosis of fetuses by providing a quantitative characterization of the normality of brain measurements.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Study Start: 2023-12-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1423

Inclusion Criteria

Child who has had, more than 3 years ago, a cerebral MRI during the fetal period in one of the 4 partner centers

Exclusion Criteria

• Child suffering from a commissural malformation (anomaly of the corpus callosum)
• Child with a genetic syndrome and/or chromosomal abnormality and/or deleterious mutation
• Child with syndromic extra-cerebral malformations (including cardiac malformations)
• Child with intrauterine growth restriction reported in the obstetrical record
• Child with maternal-fetal infection (TORCH, parvovirus or other) confirmed by amniotic fluid test or neonatal urine test
• Multiple pregnancy
• Mother with diabetes treated during pregnancy (including gestational diabetes, if treated)
• Mother with antiepileptic medication during pregnancy
• Alcohol or drug use
• Presence of a sustentorial arachnoid cyst
• Presence of an arachnoid cyst with mass effect
• Objection from parental authority holders to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine normative brain volume curves	Through study completion, an average of 3 year	Curves calculated from fetal brain MRIs in fetuses between 20 and 37 weeks of amenorrhea with normal postnatal neurological development

Secondary Outcome Measures

Name	Time	Method
Statistically compare the normative curves obtained with standard articles in the literature.	Through study completion, an average of 3 year	Comparaison of Size effect, confidence intervals obtained with those reported in the reference articles
Sensitivity study: Possible influence of the scanner type on the estimated normative curves.	Through study completion, an average of 3 year	MRI scanner model