Fetal Body Composition and Free-Breathing Magnetic Resonance Imaging
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Fetal Liver PDFF
研究概览
简要总结
Obesity is an ongoing public health problem that is difficult to treat. There is evidence that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown, and hepatic fat have been found to be important predictors in obesity and metabolic syndrome. Magnetic resonance imaging (MRI) can quantify body composition that does not require radiation but is motion limited. The investigators have developed a motion-compensated MRI sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with gestational diabetes. The different types of adipose tissue will be measured and compared between groups and correlated to birth growth parameters. The goal is this study is to assess if motion-compensated MRI can help predict early growth patterns in infancy.
详细描述
1.1 OBJECTIVE This study's goals are to: 1) use free-breathing magnetic resonance imaging (FB-MRI) to measure fetal body composition in the third trimester and 2) determine how the FB-MRI quantitative measurements compare to growth parameters at birth.
1.2 HYPOTHESES AND SPECIFIC AIMS
To accomplish the investigators' objectives, the aims and hypotheses are as follows:
Specific Aim 1:
In a prospective study in women with healthy pregnancies and women with fetuses that have intrauterine growth restriction (IUGR) and gestational diabetes, the investigators will quantify fetal subcutaneous, visceral, and brown adipose tissue volumes and proton-density fat fraction (PDFF) using FB-MRI in the third trimester.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with singleton pregnancies (healthy cohort)
- •Pregnant women with fetuses with weights < 10th percentile weight for gestational age (IUGR cohort)
- •Pregnant women with gestational diabetes (diabetes cohort)
排除标准
- •Pregnant minors
- •Major congenital anomalies or disease processes in the fetus
- •Fetus with known chromosomal anomalies
- •Mothers who do not plan to deliver at UCLA
- •Multiple pregnancy (i.e. twins, triplets, etc)
- •History of claustrophobia
- •Contraindications to MRI such as metallic devices in the body that are not MRI compatible
结局指标
主要结局
Fetal Liver PDFF
时间窗: During the procedure (MRI)
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of hepatic fat will be manually delineated/drawn on the 3D MRI images and PDFF maps. This work will be performed by PI Strobel with validation from PI Wu.
Maternal Visceral Adipose Tissue Volume
时间窗: During the procedure (MRI)
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Visceral adipose tissue PDFF values will be directly measured from regions of interest.
次要结局
- Fetal Subcutaneous Tissue Volume(During the procedure (MRI))
- Maternal Subcutaneous Tissue Volume(During the procedure (MRI))
- Maternal Hepatic Fat PDFF(During the procedure (MRI))
研究者
Katie Strobel, MD
Principle Investigator
University of California, Los Angeles