Normative Brain Volume Profiles From Multicenter Fetal MRI

NCT06081036 | Recruiting

• 1 other identifier: RCAPHM22_0324
• Study Type: observational
• Target: 1,423
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Determine normative brain volume curves

  Curves calculated from fetal brain MRIs in fetuses between 20 and 37 weeks of amenorrhea with normal postnatal neurological development

  Through study completion, an average of 3 year

Secondary Outcomes (2)

• Statistically compare the normative curves obtained with standard articles in the literature.

  Through study completion, an average of 3 year

• Sensitivity study: Possible influence of the scanner type on the estimated normative curves.

  Through study completion, an average of 3 year

Interventions

Questionnaire OTHER

Questionnaire about children development

Eligibility Criteria

• Age: 20 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Homogeneous group of fetuses who received an MRI more than 3 years ago, with normal MRI and normal neurological development at 3 years (see inclusion criteria). Included individuals (at the fetal stage) will be evaluated at 3+ years post-birth.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

CHU Timone

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Malformations of Cortical Development

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Nadine Girard, Pr

CONTACT

0413429061; nadine.girard@ap-hm.fr

Aurélie Ponz

CONTACT

0491435196; aurelie.ponz@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: October 12, 2023
• Study Start: December 2, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)