LUMIERE on the FETUS

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• feasibility of advanced MRI techniques [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]
• feasibility of advanced MRI techniques [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]
• feasibility of advanced MRI techniques [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]

Вторичные конечные точки (12)

• concordance of information collected by MRI [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]
• concordance of information collected by MRI [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]
• Concordance of information collected by MRI [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]
• Acceptability of the examination for the patient: leackertLikert scale [Срок оценки: Through MRI study completion an average of 6 months]
• Reproducibility of the examination analysis [Срок оценки: After study completion, an average of one year]
• relevance of MRI [Срок оценки: From inclusion to end of neonatal period (max 25 weeks)]
• Specific Absorption Rate for each type of sequence [Срок оценки: After study completion, an average of one year]
• feasibility of fusion imaging (echo / MRI) [Срок оценки: After study completion, an average of one year]
• norms of growth of main organs and placenta [Срок оценки: After study completion, an average of one year]
• norms of growth of main organs and placenta [Срок оценки: After study completion, an average of one year]
• norms of growth of main organs and placenta [Срок оценки: After study completion, an average of one year]
• norms of growth of main organs and placenta [Срок оценки: After study completion, an average of one year]

Критерии участия

Критерии включения

• 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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Necker - Enfants Malades Hospital — Paris

Публикации

• 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. PMID 41949001
• 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. PMID 40418192
• 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. PMID 38348601

Идентификаторы

NCT: NCT04142606 · APHP190334

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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