Normative Brain Volume Profiles From Multicenter Fetal MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire.
- Who it may be relevant to
- Registry conditions: Cortical Development Malformation, Multiparametric Magnetic Resonnance Imaging, Brain Cortical Thickness, Prenatal Diagnosis. Basic parameters: 20 Weeks — 37 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
Overview
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
- Other Questionnaire
Questionnaire about children development
Primary outcome measures
- Determine normative brain volume curves [Time frame: Through study completion, an average of 3 year]
Secondary outcome measures (2)
- Statistically compare the normative curves obtained with standard articles in the literature. [Time frame: Through study completion, an average of 3 year]
- Sensitivity study: Possible influence of the scanner type on the estimated normative curves. [Time frame: Through study completion, an average of 3 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU Timone — Marseille
Identifiers
NCT: NCT06081036 · RCAPHM22_0324