Normal fetal brain growth charts from routine MRI scans
Official title: Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
Run by Assistance Publique Hopitaux De Marseille · NCT06081036 · Data updated 2026-11-12
This project will create MRI-based charts of normal fetal brain volume using past routine scans from four French hospitals to help doctors interpret fetal brain images.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Weeks to 37 Weeks |
| Sex | All |
| Enrollment | 1423 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | September 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT06081036 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children who had a fetal brain MRI more than three years ago at one of the four partner centers and whose scans showed no abnormalities, with families willing to be contacted for follow-up questionnaires.
✕Probably not a fit
Children with corpus callosum malformations, genetic or chromosomal syndromes, syndromic extracerebral malformations, intrauterine growth restriction, confirmed maternal-fetal infection, multiple pregnancy, maternal diabetes treated during pregnancy, maternal antiepileptic drug exposure, significant alcohol or drug use, arachnoid cysts with mass effect, or whose parents object are excluded and unlikely to benefit from the normative curves.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect routine fetal brain MRIs acquired more than three years ago at four French centers (Marseille, Nice, Montpellier, Paris) and centralize scans that show no abnormalities. Families of included children will be contacted to provide postnatal development information via questionnaires. Images will be processed with automated methods developed by the Marseille laboratory to measure brain tissue volumes and cortical metrics. From these measurements the team will construct normative growth curves of fetal brain volume and cortical thickness to support prenatal diagnosis and prognosis.
Why it matters
Potential benefit: If successful, the resulting normative curves could help clinicians distinguish normal from abnormal fetal brain development and improve prenatal counseling and prognostic accuracy.
How similar studies have gone: Prior single-center research has shown that antenatal MRI measures can predict postnatal development, but multicenter normative volumetric curves derived from routine clinical fetal MRI remain largely novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU Timone
Marseille, France Recruiting
Study contacts
- Study coordinator: Nadine Girard, Pr
- Email: nadine.girard@ap-hm.fr
- Phone: 0413429061
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.