Normative Brain Volume Profiles From Multicenter Fetal MRI

NCT ID: NCT06081036

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1423 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-12-01

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Questionnaire

Questionnaire about children development

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Timone

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nadine Girard, Pr

Role: CONTACT

nadine.girard@ap-hm.fr

0413429061

Aurélie Ponz

Role: CONTACT

aurelie.ponz@ap-hm.fr

0491435196

Facility Contacts

Nadine GIRARD, MD PHD

Role: primary

Other Identifiers

RCAPHM22_0324

Identifier Type: -

Identifier Source: org_study_id