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Clinical Trials/NCT06081036
NCT06081036
Recruiting
N/A

Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques

Assistance Publique Hopitaux De Marseille1 site in 1 country1,423 target enrollmentDecember 2, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cortical Development Malformation
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
1423
Locations
1
Primary Endpoint
Determine normative brain volume curves
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2024
End Date
December 1, 2025
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Statistically compare the normative curves obtained with standard articles in the literature.(Through study completion, an average of 3 year)
  • Sensitivity study: Possible influence of the scanner type on the estimated normative curves.(Through study completion, an average of 3 year)

Study Sites (1)

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