MULTINORMFET: Normative Brain Volume Profiles From Multicenter Fetal MRI

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06081036
• Collaborator: (none)
• Enrollment: 1,423
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cortical Development Malformation; Multiparametric Magnetic Resonnance Imaging; Brain Cortical Thickness; Prenatal Diagnosis; Fetal Development	Other: Questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1423 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Outcome Measures

Primary Outcome Measures

1. 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

Secondary Outcome Measures

1. Statistically compare the normative curves obtained with standard articles in the literature. [Through study completion, an average of 3 year]

   Comparaison of Size effect, confidence intervals obtained with those reported in the reference articles

2. Sensitivity study: Possible influence of the scanner type on the estimated normative curves. [Through study completion, an average of 3 year]

   MRI scanner model

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Weeks to 37 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT06081036
• Other Study ID Numbers: RCAPHM22_0324
• First Posted: Oct 12, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Malformations of Cortical Development

Study Results

No Results Posted as of Oct 12, 2023