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Normative Brain Volume Profiles From Multicenter Fetal MRI

Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06081036
Acronym
MULTINORMFET
Enrollment
1423
Registered
2023-10-12
Start date
2024-12-02
Completion date
2025-12-01
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERQuestionnaire

Questionnaire about children development

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Weeks to 37 Weeks
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

Design outcomes

Primary

MeasureTime frameDescription
Determine normative brain volume curvesThrough study completion, an average of 3 yearCurves calculated from fetal brain MRIs in fetuses between 20 and 37 weeks of amenorrhea with normal postnatal neurological development

Secondary

MeasureTime frameDescription
Statistically compare the normative curves obtained with standard articles in the literature.Through study completion, an average of 3 yearComparaison of Size effect, confidence intervals obtained with those reported in the reference articles
Sensitivity study: Possible influence of the scanner type on the estimated normative curves.Through study completion, an average of 3 yearMRI scanner model

Countries

France

Contacts

Primary ContactNadine Girard, Pr
nadine.girard@ap-hm.fr0413429061
Backup ContactAurélie Ponz
aurelie.ponz@ap-hm.fr0491435196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026