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NCT Number: NCT04142606

LUMIERE on the FETUS

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Necker - Enfants Malades Hospital

Paris, 75015, France

Location status: Recruiting

Location contact

Laurent Salomon, MD, PhD

CONTACT

[email protected]

0144496481

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fetal MRI

Other

The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)

Primary outcomes

  1. feasibility of advanced MRI techniques

    Time frame: From inclusion to end of neonatal period (max 25 weeks)

    % of satisfactory sequences

  2. 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

  3. 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

Secondary outcomes

  1. concordance of information collected by MRI

    Time frame: From inclusion to end of neonatal period (max 25 weeks)

    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.

  2. concordance of information collected by MRI

    Time frame: From inclusion to end of neonatal period (max 25 weeks)

    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.

  3. Concordance of information collected by MRI

    Time frame: From inclusion to end of neonatal period (max 25 weeks)

    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.

  4. Acceptability of the examination for the patient: leackertLikert scale

    Time frame: Through MRI study completion an average of 6 months

    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.

  5. Reproducibility of the examination analysis

    Time frame: After study completion, an average of one year

    will be assessed by means of Kappa coefficient

  6. relevance of MRI

    Time frame: From inclusion to end of neonatal period (max 25 weeks)

    will be assessed by the % of added informations

  7. Specific Absorption Rate for each type of sequence

    Time frame: After study completion, an average of one year

    SAR is an MRI machine parameter

  8. feasibility of fusion imaging (echo / MRI)

    Time frame: After study completion, an average of one year

    will be assessed by the success rate of appropriate matching - % of successful echo-IRM fusion

  9. norms of growth of main organs and placenta

    Time frame: After study completion, an average of one year

    Creating of normal curves by MRI measurements for length at various gestational ages

  10. norms of growth of main organs and placenta

    Time frame: After study completion, an average of one year

    Creating of normal curves by MRI measurements: for width at various gestational ages

  11. norms of growth of main organs and placenta

    Time frame: After study completion, an average of one year

    Creating of normal curves by MRI measurements for height at various gestational ages

  12. norms of growth of main organs and placenta

    Time frame: After study completion, an average of one year

    Creating of normal curves by MRI measurements for volumes at various gestational ages

  13. Establishment of an anatomical and functional database on a large group of healthy fetuses

    Time frame: After study completion, an average of one year

    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

  14. Establishment of an anatomical and functional database on a large group of healthy fetuses

    Time frame: After study completion, an average of one year

    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

  15. Establishment of an anatomical and functional database on a large group of healthy fetuses

    Time frame: After study completion, an average of one year

    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

  16. Establishment of an anatomical and functional database on a large group of healthy fetuses

    Time frame: After study completion, an average of one year

    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

  17. Establishment of an anatomical and functional database on a large group of healthy fetuses

    Time frame: After study completion, an average of one year

    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

  18. Establishment of an anatomical and functional database on a large group of healthy fetuses

    Time frame: After study completion, an average of one year

    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

  19. Concordance of diagnosis

    Time frame: Termination of pregnancy (max 25 weeks)

    Concordance of diagnosis between virtual autopsy and foetopathology

Study contacts

Contact information is provided by the study sponsor or research team.

Aminata TRAORE

CONTACT

[email protected]

+ 331 48 19 27 34

David Grevent, MD PHD

CONTACT

[email protected]

+ 33144841734

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
  • URC-CIC Paris Descartes Necker Cochin
  • University of Paris 5 - Rene Descartes

Registry information

Official study title

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

Acronym: FETUS

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Oct 29, 2019
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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