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Normative Brain Volume Profiles From Multicenter Fetal MRI (MULTINORMFET)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Enrolling

Conditions

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

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT06081036
RCAPHM22_0324

Details and patient eligibility

About

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.

Enrollment

1,423 estimated patients

Sex

All

Ages

20 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Aurélie Ponz; Nadine Girard, Pr

Data sourced from clinicaltrials.gov

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