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临床试验/NCT03490656
NCT03490656Unknown不适用

Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2016年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
77
试验地点
1
主要终点
Image quality

研究概览

简要总结

The goals of this study are to (1) develop and optimize MRI acquisition and post-processing techniques and (2) to generate preliminary and comparative data on sequences for potential clinical trials.

详细描述

This prospective study will utilize investigational MRI sequences both in a volunteer population as well as in patients in addition to standard of care MR imaging to develop and optimize MRI sequence post-processing techniques as well as to generate preliminary and comparative data for potential clinical trials. These post-processing techniques include but are not limited to visual inspection of image quality and known anatomy, semi-quantitative analysis including the use of rating schemes, signal-to-noise-ratios and contrast-to-noise-ratios measurements for quantitative assessment, standard fitting procedures for measuring MRI parameters, and using various published methods for image post-processing. The MRI methodologies we plan to use as part of this study will allow us to obtain morphological, functional and molecular information. For the patient population: Patients receiving a standard of care 1.5 or 3T MRI will be asked by study personnel if they are interested in undergoing additional investigational imaging sequences after their standard of care imaging. If the patient agrees, he/she will remain in the same position on the MRI scanner for up to an additional 30 minutes while more images are obtained. Each patient will be imaged for no longer than 2 hours (standard of care imaging and additional investigational imaging). A routine clinical report will be generated for the clinically indicated MRI by a radiologist. Once this routine clinical MRI scan is dictated and finalized, a study team member will obtain the report via IHIS and manually remove all identifiers. This report is being obtained for comparative purposes. All the data being compared will be coded using a unique study number. For the volunteer population: Healthy volunteers recruited through the OSU Wexner Medical Center or accompanying patients to their standard of care imaging appointments at The Wright Center of Innovation will be asked by study personnel if they are interested in undergoing investigational MR imaging sequences. If the volunteer agrees, he/she will be imaged on the MRI scanner for up to 60 minutes while images are obtained. Other than the participant signing the informed consent form, no participant information or protected health information (PHI) will be recorded. Following the informed consent authorization, the participant's name will be coded using a unique study number.

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
是

入选标准

  • •Male and female volunteers greater than or equal to 18 years of age
  • •Patients receiving a standard of care 1.5 or 3T MRI at The Ohio State University
  • •Healthy volunteers that feel comfortable receiving an investigational mRI

排除标准

  • •Participants with a contraindication to MRI. Such contraindications include, but are not limited to: pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, tattoos, implanted electronic infusion pumps or any other condition that would interfere with the MRI, a stent somewhere, a history of allergic reaction to any metals
  • •Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
  • •Participants with vital signs outside of normal range
  • •Prisoners
  • •Subjects incapable of giving informed written consent
  • •Participants who are pregnant, healthy volunteers

研究组 & 干预措施

Healthy volunteer population

Experimental

干预措施: MRI Scan - not in addition to standard of care (Diagnostic Test)

Patient population

Experimental

干预措施: MRI Scan - in addition to standard of care (Diagnostic Test)

结局指标

主要结局

Image quality

时间窗: through study completion, an average of 1-3 years

assessed by blinded readers

Artifacts

时间窗: through study completion, an average of 1-3 years

assessed by blinded readers

Image noise

时间窗: through study completion, an average of 1-3 years

assessed region of interest over target tissue and background

Lesion detectability

时间窗: through study completion, an average of 1-3 years

assessed by blinded readers

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

Michael V Knopp MD PhD

Professor

University of Cincinnati

研究点 (1)

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