LUMIERE on the FETUS

Pregnancy Clinical Trial

— FETUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04142606
• Other study ID #: APHP190334
• Status: Recruiting
• Start date: December 6, 2019
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David Grevent, MD PHD
• Phone: + 33144841734
• Email: david.grevent[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy

Intervention

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)

Locations

Country	Name	City	State
France	Necker - Enfants Malades Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of advanced MRI techniques	% of satisfactory sequences	From inclusion to end of neonatal period (max 25 weeks)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Reproducibility of the examination analysis	will be assessed by means of Kappa coefficient	After study completion, an average of one year
Secondary	relevance of MRI	will be assessed by the % of added informations	From inclusion to end of neonatal period (max 25 weeks)
Secondary	Specific Absorption Rate for each type of sequence	SAR is an MRI machine parameter	After study completion, an average of one year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concordance of diagnosis	Concordance of diagnosis between virtual autopsy and foetopathology	Termination of pregnancy (max 25 weeks)