Advanced Fetal Imaging - Phase II

Обзор

The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing MRI coils specifically for pregnant women and testing recently developed MRI image acquisition techniques. The investigators aim to more reliably obtain higher quality fetal MRI images when compared to current clinical fetal MRI.

Подробное описание

The main aim of this project is to evaluate and optimize the existing clinical magnetic resonance (MR) techniques for fetal imaging, and to also implement and test new MR technologies that would improve fetal imaging in general. This involves the development of new pulse sequences and image acquisition schemes that "freeze" fetal motion and hence provide improved image quality and robustness for both structural (T1- and T2- weighted, susceptibility and FLAIR imaging) and physiological imaging (diffusion, perfusion, spectroscopy, resting-state functional MRI, etc). The scope of this project also includes testing of newly developed radio frequency (RF) receive-only coil arrays that would inherently provide the means for faster imaging of the fetus, and thus complement the software developments.

Вмешательства

• Устройство Investigational MRI coil designed for pregnant women
  The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.
• Процедура MRI Scan
  All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.

Первичные конечные точки

• Research fetal MRI image quality compared to standard clinical fetal MRI image quality [Срок оценки: July 2016-December 2019, up to 41 months]

Вторичные конечные точки (2)

• Research fetal MRI image quality compared to standard obstetric ultrasound image quality [Срок оценки: July 2016-December 2019, up to 41 months]
• Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound [Срок оценки: July 2016-December 2019, up to 41 months]

Критерии участия

Критерии включения

• 60 Minute Full Research MRI Scan:

• Gestational age between 18 and 40 weeks

• AND
• Pregnant women with a healthy pregnancy

• OR
• Pregnant women with a concern for fetal/placental abnormalities referred for a clinical fetal MRI by their obstetrician

• OR
• Pregnant women with a concern for fetal/placental abnormalities NOT referred for a clinical fetal MRI by their obstetrician
• 15 Minute Add-On Research Scan:

• Gestational age between 18 and 40 weeks

• AND
• Pregnant women with a concern for fetal abnormalities referred for a clinical fetal MRI by their obstetrician

• AND
• The clinical fetal MRI will occur at Boston Children's Hospital

Критерии исключения

• Pregnant women with a contraindication to MRI (implanted metal, non-removable piercings, pacemaker, etc)
• Pregnant women who are claustrophobic
• Pregnant women who are medically unstable for an MRI

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Boston Children's Hospital — Boston

Идентификаторы

NCT: NCT02840019 · R01EB017337

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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