LUMIERE on the FETUS (FETUS)

LUMIERE on the FETUS : A Study on the Added Value of Fetal MRI

Congenital anomalies are a major public health problem. They affect 2-3% of births, around 20,000 new cases per year in France, of which 15% are cared for in Ile de France. These congenital anomalies are a major cause of morbidity, infant mortality and disability. They are also a major cause of death during the infant period (22% of deaths during the first year of life: source CépiDC Inserm 2010). The detection, accurate diagnosis and accurate prognosis, particularly functional, of these congenital anomalies are still difficult in the current monitoring of pregnancy, which is based primarily on ultrasound. The use and development of modern imaging techniques is now essential to enable doctors to better see and better examine the fetus. Alongside ultrasound, Magnetic Resonance Imaging (MRI) is a technique that has undergone significant development in recent years. MRI must allow the effective anatomical and functional evaluation of the main fetal organs and could in particular be interesting in several situations in which it has not yet been sufficiently evaluated and is not yet performed in clinical routine.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Other: fetal MRI

Detailed Description

The inclusion will take place from 16WF to 36WG, within the framework of one of the 4 clinical subgroups of patients envisaged.

The standardized anatomic and functional MRI examination will in all cases last less than 45 minutes and will be based on sequences already used in clinical practice.

Clinical, biological, and ultrasound data will be collected prospectively and used for the usual management of the patient. For the purposes of the study, these data will be secondarily anonymized and analyzed in connection with the MRI data and the perinatal outcome to meet the specific objectives.

The lost-to-follow-up bias will be limited by the simplicity of the proposed perinatal surveillance, which does not differ from the surveillance usually recommended for these pregnancies

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Aminata TRAORE; Phone Number: + 331 48 19 27 34; Email: aminata.traore6@aphp.fr
• Study Contact Backup: Name: David Grevent, MD PHD; Phone Number: + 33144841734; Email: david.grevent@gmail.com

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Necker - Enfants Malades Hospital
    • Contact: Laurent Salomon, MD, PhD; Phone Number: 0144496481; Email: laurentsalomon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients followed in the Fetal Medicine Department of the Necker-Enfants Malades hospital belonging to one of the following 4 groups:

• Having prenatal ultrasound screening without detected abnormality
• Having an ultrasound examination without abnormality detected but in whom ultrasound examination is not optimal (poor technical conditions, multiple pregnancies, obese patients)
• Standardized prenatal screening with ultrasound examination finding an isolated anomaly that does not currently constitute a commonly accepted indication of fetal MRI
• A medical termination of pregnancy, in addition to a fetopathological examination (virtopsy)

Description

Inclusion Criteria:

• patient ≥ 18 years
• Single or twin pregnancy
• gestational age≥ 16 WG and ≤ 36 WG based on cranio-caudal length (LCC) dating
• Collection of the patient's consent

Exclusion Criteria:

contraindication to MRI

• multiple pregnancies > 2
• subsequent follow-up impossible
• maternal condition contraindicates continuation of pregnancy
• patient having to have an MRI examination as part of the normal clinical follow-up of her pregnancy (identified or strongly suspected echocardiographic abnormality on ultrasound, diaphragmatic dome hernia, CMV fetal infection, antecedent brain abnormality in siblings, STT operated)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group (Group 1); Having prenatal ultrasound screening without detected abnormality	Other: fetal MRI; The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
Non Optimal Ultrasound Scan Group (Group 2); Having an ultrasound examination without abnormality detected but in whom ultrasound examination is not optimal (poor technical conditions, multiple pregnancies, obese patients)	Other: fetal MRI; The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
Malformation Group (Group 3); Standardized prenatal screening with ultrasound examination finding an isolated anomaly that does not currently constitute a commonly accepted indication of fetal MRI	Other: fetal MRI; The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
TOP Group (Group 4); A medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy)	Other: fetal MRI; The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of advanced MRI techniques	% of satisfactory sequences	From inclusion to end of neonatal period (max 25 weeks)
feasibility of advanced MRI techniques	quality of standardized morphological fetal examination using recognizable criteria of normality	From inclusion to end of neonatal period (max 25 weeks)
feasibility of advanced MRI techniques	quality of standardized functional fetal examination using recognizable criteria of normality	From inclusion to end of neonatal period (max 25 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance of information collected by MRI	Concordance of the diagnosis carried out on each standardized section in ultrasound, MRI and the final diagnosis: Standardized cuts with main anatomical landmarks seen and of usual appearance.	From inclusion to end of neonatal period (max 25 weeks)
concordance of information collected by MRI	Concordance of the diagnosis carried out on each standardized section in ultrasound, MRI and the final diagnosis: Standardized cuts with main anatomical landmarks seen and unusual appearance.	From inclusion to end of neonatal period (max 25 weeks)
Concordance of information collected by MRI	Concordance of the diagnosis carried out on each standardized section in ultrasound, MRI and the final diagnosis: Standardized cuts with main non-evaluable anatomical landmarks.	From inclusion to end of neonatal period (max 25 weeks)
Acceptability of the examination for the patient: leackertLikert scale	will be assessed by a Likert scale. which is a psychometric tool for measuring an attitude in individuals. It consists of one or more statements (statements or items) for which the respondent expresses her degree of agreement or disagreement (5 items from 1 to 5 points : from "very poor", "poor", "average", "good", "very good"). A scale of several items can be summarized by the average of the item scores.	Through MRI study completion an average of 6 months
Reproducibility of the examination analysis	will be assessed by means of Kappa coefficient	After study completion, an average of one year
relevance of MRI	will be assessed by the % of added informations	From inclusion to end of neonatal period (max 25 weeks)
Specific Absorption Rate for each type of sequence	SAR is an MRI machine parameter	After study completion, an average of one year
feasibility of fusion imaging (echo / MRI)	will be assessed by the success rate of appropriate matching - % of successful echo-IRM fusion	After study completion, an average of one year
norms of growth of main organs and placenta	Creating of normal curves by MRI measurements for length at various gestational ages	After study completion, an average of one year
norms of growth of main organs and placenta	Creating of normal curves by MRI measurements: for width at various gestational ages	After study completion, an average of one year
norms of growth of main organs and placenta	Creating of normal curves by MRI measurements for height at various gestational ages	After study completion, an average of one year
norms of growth of main organs and placenta	Creating of normal curves by MRI measurements for volumes at various gestational ages	After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses	Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal brain acquired thought gestation and anatomical and using functionnal sequences	After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses	Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal thorax acquired thought gestation and anatomical and using functionnal sequences	After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses	Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal heart acquired thought gestation and anatomical and using functionnal sequences	After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses	Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal abdomen acquired thought gestation and anatomical and using functionnal sequences	After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses	Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal limb acquired thought gestation and anatomical and using functionnal sequences	After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses	Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of placenta acquired thought gestation and anatomical and using functionnal sequences	After study completion, an average of one year
Concordance of diagnosis	Concordance of diagnosis between virtual autopsy and foetopathology	Termination of pregnancy (max 25 weeks)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of Paris 5 - Rene Descartes; URC-CIC Paris Descartes Necker Cochin; LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
• Investigators: Principal Investigator: Laurent Salomon, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Bouachba A, Bartin R, De Jesus Neves J, Bussieres L, Grevent D, Virfollet J, Gauchard G, Bobet L, Roux N, Glemain B, Salomon LJ, Gorincour G. Normative range of MRI-based fetal body volume and association with ultrasonographically estimated fetal weight at 16-36 weeks: prospective study. Ultrasound Obstet Gynecol. 2025 Jul;66(1):81-88. doi: 10.1002/uog.29234. Epub 2025 May 26.
• Bartin R, Melbourne A, Bobet L, Gauchard G, Menneglier A, Grevent D, Bussieres L, Siauve N, Salomon LJ. Static and dynamic responses to hyperoxia of normal placenta across gestation with T2*-weighted MRI sequences. Ultrasound Obstet Gynecol. 2024 Aug;64(2):236-244. doi: 10.1002/uog.27609.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: APHP190334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No