Normative Brain Volume Profiles From Multicenter Fetal MRI

Prenatal Diagnosis Clinical Trial

— MULTINORMFET  

Official title:

Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06081036
• Other study ID #: RCAPHM22_0324
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Nadine Girard, Pr
• Phone: 0413429061
• Email: nadine.girard[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1423
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Fetal Development
• Prenatal Diagnosis

Intervention

Other:
• Questionnaire
Questionnaire about children development

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sensitivity study: Possible influence of the scanner type on the estimated normative curves.	MRI scanner model	Through study completion, an average of 3 year