Normative Brain Volume Profiles From Multicenter Fetal MRI (MULTINORMFET)

Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fetal Development; Prenatal Diagnosis; Cortical Development Malformation; Multiparametric Magnetic Resonnance Imaging; Brain Cortical Thickness
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 1423

Contacts and Locations

• Study Contact: Name: Nadine Girard, Pr; Phone Number: 0413429061; Email: nadine.girard@ap-hm.fr
• Study Contact Backup: Name: Aurélie Ponz; Phone Number: 0491435196; Email: aurelie.ponz@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Malformations of Cortical Development
• Other Study ID Numbers: RCAPHM22_0324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No