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临床试验/NCT04629469
NCT04629469招募中不适用

Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US

研究概览

简要总结

Hyperfine Research, Inc. has taken advantage of technological advances and developed an MRI device that is not only portable, but also uses a very-low magnetic field strength, [less than 0.2 Tesla or approximately 10 times less] than the field strength of conventional devices. This critical difference allows HRI to address MRI's core challenges by, first, operating at very low magnetic field strengths, eliminating the need for special rooms or shielding. Second, there are minimal safety concerns regarding ferrous metals near the system, as the field strength is too low to attract metal objects. The removal of metal, including items such as jewelry, belts, etc. from clothing and person, prior to being scanned, is unnecessary. Third, the design constraints faced by conventional MRI systems are lifted at low magnetic field and an open device has been designed to minimize anxiety that may come with claustrophobic patients. All of this is possible while still providing image quality that is clinically relevant to a wide variety of fields, including radiology, neurology, pediatrics, emergency medicine, and others.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
0 Days 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.

排除标准

  • No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.
  • Any patient who has a contraindication to having an MRI, such as:
  • Non-MRI conditional implanted device or device that is not able to be removed for MRI examination

研究组 & 干预措施

Hyperfine

Experimental

For patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams.

干预措施: Hyperfine MRI (Diagnostic Test)

结局指标

主要结局

Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US

时间窗: Through study completion, an average of one year

Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US

次要结局

未报告次要终点

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherwin Chan MD PhD

Principal Investigator

Children's Mercy Hospital Kansas City

研究点 (1)

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