NCT06081036 Normative Brain Volume Profiles From Multicenter Fetal MRI
| NCT ID | NCT06081036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Cortical Development Malformation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,423 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,423 participants in total. It began in 2024-12-02 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06081036 clinical trial?
This trial is open to participants of all sexes, aged 20 Weeks or older, up to 37 Weeks, studying Cortical Development Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06081036 currently recruiting?
Yes, NCT06081036 is actively recruiting participants. Contact the research team at nadine.girard@ap-hm.fr for enrollment information.
Where is the NCT06081036 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06081036 clinical trial?
NCT06081036 is sponsored by Assistance Publique Hopitaux De Marseille. The trial plans to enroll 1,423 participants.