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临床试验/NCT04436068
NCT04436068已完成不适用

Evaluation of Hyperfine Low Field Strength Portable Point-of-Care Magnetic Resonance Imaging System in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Presence of hydrocephalus

研究概览

简要总结

Participants with known or suspected hydrocephalus will receive brain scans using the Hyperfine, low field strength, portable, magnetic resonance imaging (MRI) system in addition to their scheduled outpatient standard of care clinical computed tomography (CT) or MRI scan. The purpose of this pilot study is to evaluate the feasibility and acceptability of using the Hyperfine system in an outpatient setting and to compare its diagnostic performance to standard clinical imaging.

Outpatients with other known or suspected neurological disorders or conditions prompting routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic performance of low field scans compared to that of the same day standard of care clinical imaging.

详细描述

Hydrocephalus is a medical condition in which an abnormal buildup of cerebrospinal fluid (CSF) causes the fluid-filled spaces of the brain, the ventricles, to become enlarged. Enlarged ventricles and increased intracranial pressure can cause headaches, dizziness, blurred vision, cognitive impairment, gait disturbances and in severe cases even brain herniation or death. A tube or shunt can be inserted into the ventricles to drain the CSF either outside the body temporarily or into the abdominal cavity for long-term treatment. Sometimes such shunts need to be adjusted or replaced if fluid re-accumulates. Medical imaging scans, either computer tomography (CT) or magnetic resonance imaging (MRI), are used to diagnose hydrocephalus in adults and children.

The purpose of this pilot study is to assess the performance of a newly developed, portable, low-cost MRI machine (Hyperfine MRI) in diagnosing and following patients with hydrocephalus in comparison to routine clinical CT or MRI. Outpatients with known or suspected hydrocephalus with or without ventricular shunts will be recruited to undergo Hyperfine MRI in conjunction with their routine clinical imaging. We will evaluate both the feasibility and acceptability of using the Hyperfine unit in the outpatient setting as well as the performance of Hyperfine MRI images in identifying hydrocephalus and other key brain imaging features relative to routine CT and MRI.

Outpatients with other known or suspected neurological disorders or conditions prompting routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic performance of low field scans compared to that of the same day standard of care clinical imaging.

研究设计

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

入排标准

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

入选标准

  • Age 18 years or older
  • Suspected or confirmed diagnosis of hydrocephalus from Penn referring physician
  • Other suspected or confirmed neurological disorder from Penn referring physician
  • Routine clinical CT or MRI of the brain scheduled/obtained on the same day as Hyperfine imaging.
  • Informed consent obtained from patient or legally authorized representative

排除标准

  • Contraindications to routine 1.5T MRI evaluation, including electrical implants such as cardiac pacemakers or perfusion pumps, ferromagnetic implants such as aneurysm clips, surgical clips, protheses, artificial hearts or heart valves with steel parts, metal fragments, shrapnel, tattoos near the eye, steel implants, or other irremovable ferromagnetic objects
  • History of uncontrolled seizures
  • Claustrophobia
  • Weight greater than or equal to 400lbs (181.4kg)
  • Pregnancy
  • Inability or suspected inability to comply with the study procedures

研究组 & 干预措施

Outpatients with known or suspected hydrocephalus

Experimental

干预措施: Hyperfine MRI scan (Device)

Outpatients with other known or suspected neurological condition

Experimental

干预措施: Hyperfine MRI scan (Device)

结局指标

主要结局

Presence of hydrocephalus

时间窗: Through study completion, an average of 60 minutes

Presence or absence of hydrocephalus will be determined qualitatively based on neuroradiologist interpretation of low-field MRI scans and companion standard clinical MRI or CT scans to evaluate performance using the low-field device to make this determination.

Quantitative ventricular volumes

时间窗: Through study completion, an average of 60 minutes

Quantitative ventricular volumes (mL) will be obtained and compared for low-field and companion standard clinical MRI scans.

Presence of other important imaging findings

时间窗: Through study completion, an average of 60 minutes

Presence of other important imaging findings will be determined qualitatively based on neuroradiologist interpretation of low-field MRI scans and companion standard clinical MRI or CT scans.

次要结局

未报告次要终点

研究者

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

Joel M. Stein, MD, PhD

Assistant Professor of Radiology

University of Pennsylvania

研究点 (1)

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