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临床试验/NCT00870675
NCT00870675已完成不适用

MRI of Ventriculomegaly: Morphology and Outcome

National Institute for Biomedical Imaging and Bioengineering (NIBIB)1 个研究点 分布在 1 个国家目标入组 434 人开始时间: 1996年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
434
试验地点
1
主要终点
Live birth

研究概览

简要总结

This study compares the accuracy of fast magnetic resonance imaging (MRI) using the half Fourier single shot rapid acceleration with relaxation enhancement technique to ultrasound in the diagnosis of fetal abnormalities. The investigators' specific aim is to perform MRI examinations with ultrafast MRI on fetuses with sonographic morphologic abnormalities. The investigators' hypotheses are that 1) MRI will demonstrate fetal morphologic abnormalities; and 2) MRI will add additional information to the sonographic diagnosis which may directly affect maternal and/or neonatal care.

详细描述

  1. Study Design: This is a descriptive study looking at the potential for MRI to aid in the diagnosis of fetal ventriculomegaly. It will also compare the specificity of MRI and ultrasound in diagnosing additional morphologic abnormalities.

450 pregnant women in the second and third trimester with ventriculomegaly will be asked to participate. Sonograms will be performed according the American Institute of Ultrasound in Medicine/American College of Radiology guidelines. In addition, views will be obtained of the fetal face, lips, outflow tracts, hands, and feet.

The gestational age of the fetus, interpretation of the sonogram, with sonographic abnormality and specific diagnosis will be prospectively recorded. Other data collected will be age and ethnicity of the patient, results of chromosomal analysis during the current pregnancy, and gestational age at the time of original diagnosis of abnormality during this pregnancy.

After screening for contraindications to MRI examination patients will undergo a 20 minute MRI examination. MRI examinations will be performed with a 1.5 T superconductive system (SIEMENS VISION, Erlangen, Germany or General Electric Twin, Milwaukee) using a 4-8 element body phased-array coil and/or body coil. The minimum rise time will be 600 microseconds (for a 25 milliTesla preset gradient amplitude). The whole body specific absorption rate will be kept under 1.5 watt/kilogram. Patients will be positioned supine with their feet entering the magnet bore first to minimize feelings of claustrophobia. A scout view will be obtained, and fetal images will be obtained with half Fourier single shot fast spin echo imaging imaging in the fetal sagittal, coronal, and axial planes (echo spacing of 4.2 msec, echo time=60 msec, echo train length=72, 1 acquisition, 3-5 mm section thickness, 26 x 35 cm field of view, 128 x 256 acquisition matrix). The refocusing flip angle will be minimized to decrease the amount of radiofrequency power deposition. Fetal anomalies seen with MRI will be recorded prospectively with knowledge of the sonographic findings.

Interpretation of the sonograms will be performed independently of the MR results. Interpretation of MRI examinations will be performed by reviewers with knowledge of the results of the ultrasound. The principal investigator will then combine the results from the two modalities. When the diagnosis differs between the modalities, the images will be reviewed by three radiologists and a consensus will be reached. The results of the sonogram and MRI will be communicated to the referring physician. Affect of any change in patient care will be assessed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Sonographic finding of ventriculomegaly
  • Ability and willingness of the patient to provide informed consent and cooperate for the examination
  • Absence of contraindications for MRI (claustrophobia, pacemaker, intracranial clips, intra-articular ocular debris)
  • All patients must be greater than 18 years old and must be in the second or third trimester of pregnancy

排除标准

  • Contraindications to MRI
  • Age less than 18
  • First trimester of pregnancy

结局指标

主要结局

Live birth

时间窗: within 6 months of enrollment

Postnatal imaging abnormalities

时间窗: Within 3 years of birth

Postnatal developmental delay

时间窗: Within 3 years of birth

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Deborah Levine

Professor of Radiology

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

研究点 (1)

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