Advanced Fetal Imaging - Phase II
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Research fetal MRI image quality compared to standard clinical fetal MRI image quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •60 Minute Full Research MRI Scan:
- •Gestational age between 18 and 40 weeks
- •Pregnant women with a healthy pregnancy
- •Pregnant women with a concern for fetal/placental abnormalities referred for a clinical fetal MRI by their obstetrician
- •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
- •Pregnant women with a concern for fetal abnormalities referred for a clinical fetal MRI by their obstetrician
- •The clinical fetal MRI will occur at Boston Children's Hospital
排除标准
- •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
研究组 & 干预措施
60 minute research full MRI scan
Pregnant women who are able to have an MRI are eligible for the 60 minute research full MRI scan. Pregnant women may have a healthy pregnancy, a concern for fetal/placental abnormalities with a clinical fetal MRI ordered by their doctor, or a concern for fetal/placental abnormalities without a clinical fetal MRI ordered by their doctor.
The investigational MRI coil designed for pregnant women and research MRI sequences will be tested during the 60 minute research scan.
干预措施: MRI Scan (Procedure)
60 minute research full MRI scan
Pregnant women who are able to have an MRI are eligible for the 60 minute research full MRI scan. Pregnant women may have a healthy pregnancy, a concern for fetal/placental abnormalities with a clinical fetal MRI ordered by their doctor, or a concern for fetal/placental abnormalities without a clinical fetal MRI ordered by their doctor.
The investigational MRI coil designed for pregnant women and research MRI sequences will be tested during the 60 minute research scan.
干预措施: Investigational MRI coil designed for pregnant women (Device)
15 minute research add-on MRI scan
Pregnant women with a concern for fetal/placental abnormalities with a clinical fetal MRI at Boston Children's Hospital are eligible for the 15 minute research add-on MRI scan.
The research MRI sequences will also be tested during the add-on research MRI scan.
干预措施: MRI Scan (Procedure)
结局指标
主要结局
Research fetal MRI image quality compared to standard clinical fetal MRI image quality
时间窗: July 2016-December 2019, up to 41 months
Research fetal MRI image quality will be compared to the standard clinical fetal MRI image quality.
次要结局
- Research fetal MRI image quality compared to standard obstetric ultrasound image quality(July 2016-December 2019, up to 41 months)
- Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound(July 2016-December 2019, up to 41 months)
研究者
Ellen Grant
Professor
Boston Children's Hospital