Clinical trial NCT06081036: Normative Brain Volume Profiles From Multicenter Fetal MRI
Official title: Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cortical Development Malformation
Multiparametric Magnetic Resonnance Imaging
Brain Cortical Thickness
Prenatal Diagnosis
Fetal Development
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 1423
Sex: ALL
Minimum age (years): 20
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Homogeneous group of fetuses who received an MRI more than 3 years ago, with normal MRI and normal neurological development at 3 years (see inclusion criteria). Included individuals (at the fetal stage) will be evaluated at 3+ years post-birth.

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.


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
* Presence of an arachnoid cyst with mass effect
* Objection from parental authority holders to participate in the study

Primary outcomes:
measure: Determine normative brain volume curves
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
measure: Statistically compare the normative curves obtained with standard articles in the literature.
timeFrame: Through study completion, an average of 3 year
measure: Sensitivity study: Possible influence of the scanner type on the estimated normative curves.
timeFrame: Through study completion, an average of 3 year
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHU Timone
Study officials:
References: