LUMIERE on the FETUS : A Study on the Added Value of Fetal MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- feasibility of advanced MRI techniques
Study Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Acceptability of the examination for the patient: leackertLikert scale(Through MRI study completion an average of 6 months)
- Reproducibility of the examination analysis(After study completion, an average of one year)
- Specific Absorption Rate for each type of sequence(After study completion, an average of one year)
- Concordance of diagnosis(Termination of pregnancy (max 25 weeks))
- concordance of information collected by MRI(From inclusion to end of neonatal period (max 25 weeks))
- feasibility of fusion imaging (echo / MRI)(After study completion, an average of one year)
- norms of growth of main organs and placenta(After study completion, an average of one year)
- Establishment of an anatomical and functional database on a large group of healthy fetuses(After study completion, an average of one year)
- Concordance of information collected by MRI(From inclusion to end of neonatal period (max 25 weeks))
- relevance of MRI(From inclusion to end of neonatal period (max 25 weeks))