PregnancyFETUSNCT04142606
LUMIERE on the FETUS
An observational study of Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- fetal MRI
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2019to Jun 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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)
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
Necker - Enfants Malades Hospital
Paris, 75015
Laurent Salomon, MD, PhD, 0144496481, laurentsalomon@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Pregnancy
- Being tested
- fetal MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal MRIOther
The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Group 1) | Having prenatal ultrasound screening without detected abnormality Receives: Other: fetal MRI | |
| 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) Receives: Other: fetal MRI | |
| 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 Receives: Other: fetal MRI | |
| TOP Group (Group 4) | A medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy) Receives: Other: fetal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of advanced MRI techniques
% of satisfactory sequences
Measured: 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
Measured: 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
Measured: From inclusion to end of neonatal period (max 25 weeks)
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through MRI study completion an average of 6 months
Reproducibility of the examination analysis
will be assessed by means of Kappa coefficient
Measured: After study completion, an average of one year
relevance of MRI
will be assessed by the % of added informations
Measured: From inclusion to end of neonatal period (max 25 weeks)
Specific Absorption Rate for each type of sequence
SAR is an MRI machine parameter
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After study completion, an average of one year
Concordance of diagnosis
Concordance of diagnosis between virtual autopsy and foetopathology
Measured: Termination of pregnancy (max 25 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start6 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France, University of Paris 5 - Rene Descartes, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laurent Salomon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142606
- Sponsor's protocol ID
- APHP190334
- Acronym
- FETUS
- Status last verified
- Oct 2025
- First submitted
- 4 Sep 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouachba A, Chabourlin J, Grevent D, Neves JJ, Bussieres L, Vaillant S, Salomon LJ, Gorincour G. Normative range for MRI amniotic fluid volume from 16 to 36 gestational weeks: Absolute and relative values, and correlation to ultrasound. Acta Obstet Gynecol Scand. 2026 May;105(5):878-886. doi: 10.1111/aogs.70153. Epub 2026 Apr 8.
PubMed 41949001Bouachba 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.
PubMed 40418192Bartin 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.
PubMed 38348601
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUMIERE on the FETUS : A Study on the Added Value of Fetal MRI
- ClinicalTrials.gov ID
- NCT04142606
- Acronym / sponsor ID
- FETUS / APHP190334
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France, University of Paris 5 - Rene Descartes, URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Oct 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group (Group 1) | – | Other: fetal MRIHaving prenatal ultrasound screening without detected abnormality |
| Non Optimal Ultrasound Scan Group (Group 2) | – | Other: fetal MRIHaving an ultrasound examination without abnormality detected but in whom ultrasound examination is not optimal (poor technical conditions, multiple pregnancies, obese patients) |
| Malformation Group (Group 3) | – | Other: fetal MRIStandardized prenatal screening with ultrasound examination finding an isolated anomaly that does not currently constitute a commonly accepted indication of fetal MRI |
| TOP Group (Group 4) | – | Other: fetal MRIA medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| fetal MRIThe MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s) | Other | Control Group (Group 1), Malformation Group (Group 3), Non Optimal Ultrasound Scan Group (Group 2), TOP Group (Group 4) |
Primary outcome
feasibility of advanced MRI techniques
Time frame: From inclusion to end of neonatal period (max 25 weeks)
% of satisfactory sequences
feasibility of advanced MRI techniques
Time frame: From inclusion to end of neonatal period (max 25 weeks)
quality of standardized morphological fetal examination using recognizable criteria of normality
feasibility of advanced MRI techniques
Time frame: From inclusion to end of neonatal period (max 25 weeks)
quality of standardized functional fetal examination using recognizable criteria of normality
19 secondary outcomes
concordance of information collected by MRI
Time frame: From inclusion to end of neonatal period (max 25 weeks)
concordance of information collected by MRI
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Concordance of information collected by MRI
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Acceptability of the examination for the patient: leackertLikert scale
Time frame: Through MRI study completion an average of 6 months
Reproducibility of the examination analysis
Time frame: After study completion, an average of one year
relevance of MRI
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Specific Absorption Rate for each type of sequence
Time frame: After study completion, an average of one year
feasibility of fusion imaging (echo / MRI)
Time frame: After study completion, an average of one year
norms of growth of main organs and placenta
Time frame: After study completion, an average of one year
norms of growth of main organs and placenta
Time frame: After study completion, an average of one year
norms of growth of main organs and placenta
Time frame: After study completion, an average of one year
norms of growth of main organs and placenta
Time frame: After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses
Time frame: After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses
Time frame: After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses
Time frame: After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses
Time frame: After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses
Time frame: After study completion, an average of one year
Establishment of an anatomical and functional database on a large group of healthy fetuses
Time frame: After study completion, an average of one year
Concordance of diagnosis
Time frame: Termination of pregnancy (max 25 weeks)
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 20 Nov 2025.
- Derived from this study: PubMed 41949001Bouachba A, Chabourlin J, Grevent D, Neves JJ, Bussieres L, Vaillant S, Salomon LJ, Gorincour G. Normative range for MRI amniotic fluid volume from 16 to 36 gestational weeks: Absolute and relative values, and correlation to ultrasound. Acta Obstet Gynecol Scand. 2026 May;105(5):878-886. doi: 10.1111/aogs.70153. Epub 2026 Apr 8.
- Derived from this study: PubMed 40418192Bouachba 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.
- Derived from this study: PubMed 38348601Bartin 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.
- 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.
Laurent Salomon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Pregnancy, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 5 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 20 Nov 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 David Grevent, MD PHD (+ 33144841734, david.grevent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of advanced MRI techniques (time frame: From inclusion to end of neonatal period (max 25 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142606, which also lists 3 linked publications.
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 20 Nov 2025.