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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2020年10月1日

概览

阶段
不适用
干预措施
Hyperfine MRI
疾病 / 适应症
Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
发起方
Children's Mercy Hospital Kansas City
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
状态
招募中
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2020年10月1日
结束日期
2030年12月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Children's Mercy Hospital Kansas City
责任方
Principal Investigator
主要研究者

Sherwin Chan MD PhD

Principal Investigator

Children's Mercy Hospital Kansas City

入排标准

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

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

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

研究点 (1)

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