Cortical Development MalformationMULTINORMFETNCT06081036
Normative Brain Volume Profiles From Multicenter Fetal MRI
An observational study of Cortical Development Malformation and Multiparametric Magnetic Resonnance Imaging, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Cortical Development Malformation, Multiparametric Magnetic Resonnance Imaging, Brain Cortical Thickness
- What is being tested?
- Questionnaire
- How many people
- 1,423 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Child who has had, more than 3 years ago, a cerebral MRI during the fetal period in one of the 4 partner centers
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Timone
Marseille, 13005
Nadine GIRARD, MD PHD
About this study
Official title: Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
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.
- Conditions
- Cortical Development Malformation, Multiparametric Magnetic Resonnance Imaging, Brain Cortical Thickness, Prenatal Diagnosis, Fetal Development
- Being tested
- Questionnaire
- Medical subject headings
- Malformations of Cortical Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire about children development
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine normative brain volume curves
Curves calculated from fetal brain MRIs in fetuses between 20 and 37 weeks of amenorrhea with normal postnatal neurological development
Measured: Through study completion, an average of 3 year
Secondary outcomes (2)
Statistically compare the normative curves obtained with standard articles in the literature.
Comparaison of Size effect, confidence intervals obtained with those reported in the reference articles
Measured: Through study completion, an average of 3 year
Sensitivity study: Possible influence of the scanner type on the estimated normative curves.
MRI scanner model
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start2 Dec 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical Development MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,423 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081036
- Sponsor's protocol ID
- RCAPHM22_0324
- Acronym
- MULTINORMFET
- Status last verified
- Jun 2025
- First submitted
- 25 May 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
- ClinicalTrials.gov ID
- NCT06081036
- Acronym / sponsor ID
- MULTINORMFET / RCAPHM22_0324
- Conditions
- Cortical Development Malformation, Multiparametric Magnetic Resonnance Imaging, Brain Cortical Thickness, Prenatal Diagnosis, Fetal Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,423 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Child who has had, more than 3 years ago, a cerebral MRI during the fetal period in one of the 4 partner centers
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire about children development | Other | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortical Development Malformation and Multiparametric Magnetic Resonnance Imaging, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Girard, Pr (0413429061, nadine.girard@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine normative brain volume curves (time frame: Through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.