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NCT Number: NCT06081036

Normative Brain Volume Profiles From Multicenter Fetal MRI

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.

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Key information

Conditions

Cortical Development Malformation Brain Cortical Thickness Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fetal Development Malformations of Cortical Development Multiparametric Magnetic Resonnance Imaging Nervous System Diseases Nervous System Malformations Prenatal Diagnosis

Age range

20 week–37 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Timone

Marseille, 13005, France

Location status: Recruiting

Location contact

Nadine GIRARD, MD PHD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaire about children development

Primary outcomes

  1. Determine normative brain volume curves

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: Through study completion, an average of 3 year

    MRI scanner model

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Ponz

CONTACT

[email protected]

0491435196

Nadine Girard, Pr

CONTACT

[email protected]

0413429061

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques

Acronym: MULTINORMFET

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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