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Recruiting Observational

Normative Brain Volume Profiles From Multicenter Fetal MRI

NCT06081036 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-12-02
Last updated
2025-06-11

Condition(s) studied

Cortical Development MalformationMultiparametric Magnetic Resonnance ImagingBrain Cortical ThicknessPrenatal DiagnosisFetal Development

Investigational drug(s) / intervention(s)

Questionnaire

Questionnaire: Questionnaire about children development

Study 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.

Eligibility

Sex
ALL
Min age
20 Weeks
Max age
37 Weeks
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
CHU Timone Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06081036 on ClinicalTrials.gov ↗ ← All trials in France