MRI Technology for Greater Efficiency and Improved Value
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Difference in Image quality
研究概览
简要总结
The goal of this clinical trial is to find out if new Magnetic Resonance Imaging (MRI) computer software will:
- help make scans and exams faster
- reduce artifacts
- make MRI easier to understand
- allow technicians to focus more on the participant and less on the scanner
Participants will complete one brain MRI imaging session, lasting about 60 minutes.
详细描述
The overall goal of this application is to design technologies that improve the value of MRI, and specifically mitigate many of the complications that negatively impact this value. The scope of MRI value is vast, but can be expressed by efficiency (high patient throughput and consistent image quality), accessibility (better scope of use and equity of availability), safety, and user experience for the patient, technologist, and interpreting physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Healthy Controls Inclusion Criteria:
- •Adults at least 18 years
- •Able to provide written informed consent on their own behalf
- •Brain MR Inclusion Criteria:
- •Adults at least 18 years
- •Able to provide written informed consent on their own behalf
- •Scheduled for standard of care brain MRI
排除标准
- •Unable or unwilling to provide informed consent
- •Contraindication(s) to or inability to undergo MRI
- •Currently pregnant
- •Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed as long as the following criteria are met:
- •participant has their own prescription for the medication
- •informed consent process is conducted prior to the self-administration of the medication
- •they come to the research visit with a driver
研究组 & 干预措施
Healthy Participants - Tau
Participants not otherwise undergoing a brain MRI
干预措施: Brain MRI - spiral (Device)
Healthy Participants - Scan Efficiency
Participants not otherwise undergoing a brain MRI
干预措施: Brain MRI - SOC and spiral (Device)
Healthy Participants - image quality
Participants not otherwise undergoing a brain MRI
干预措施: Brain MRI - SOC and spiral (Device)
Healthy Participants - SNR
Participants not otherwise undergoing a brain MRI
干预措施: Brain MRI - spiral (Device)
Healthy Participants - Gradient Derating
Participants not otherwise undergoing a brain MRI
干预措施: Brain MRI - spiral (Device)
Standard of Care (SOC) Brain MRI
Participants undergoing SOC MRI
干预措施: Brain MRI (Device)
结局指标
主要结局
Difference in Image quality
时间窗: 60 minutes
Based on the results of the other 5 outcome measures, specifically whether scan time impacts image quality, the desired time will be used and scans will be compared between SOC and their method. Image quality will be measured using a 5-point Likert scale, where 1= A much worse than B, 2=A slightly worse than B, 3=A comparable to B, 4=A slightly better than B, 5=A much better than B. A=new spiral scans and B=SOC scans.
Image quality - decreasing scan time
时间窗: 60 minutes
Participants will be scanned using 2 versions (standard and spiral) of 6 sequences (12 scans total). For each sequence pair, scan time will be sped up. Image quality will be compared between the 2 versions.
Image quality - tau
时间窗: 60 minutes
Measuring whether image quality is sufficient for routine diagnostic interpretation - specifically robustness to artifacts. The independent variable is a scanning parameter called tau, which researchers want to be long (because it makes the total scan time shorter). Researchers will compare the value of tau between SOC imaging and spiral. They will use a 5-point Likert scale to compare, where 1= undiagnostic (unacceptable), 2 = spiral scans slightly worse than SOC but acceptable, 3= spiral scans same as SOC (acceptable), 4= spiral scans slightly better than SOC (acceptable), 5=spiral scans much better than SOC (acceptable).
Image quality - consistent scan time
时间窗: 60 minutes
Participants will be scanned using 2 versions (standard and designed) of 6 sequences (12 scans total). Scan time will remain the same for each pair. Radiologists will compare each pair for differences in image quality using a 5-point Likert scale where 1= A much worse than B, 2=A slightly worse than B, 3=A comparable to B, 4=A slightly better than B, 5=A much better than B. A=new spiral scans and B=SOC scans.
Signal to Noise Ratio (SNR)
时间窗: 60 minutes
Measuring the SNR in images, by measuring the signal strength in the image and the calculated noise in those images and taking the ratio. Researchers will compare this SNR to that which their methods predicted.
Image quality - acoustic comfort
时间窗: 60 minutes
Image quality will be compared between running at full strength, which is noisy, and running at reduced strength, which should be quieter. A 5-point Likert scale will be used, where 1= A much worse than B, 2=A slightly worse than B, 3=A comparable to B, 4=A slightly better than B, 5=A much better than B. A=spiral scans with full gradient strength and B=spiral scans with reduced gradient strength (that should be quieter).
Acoustic noise
时间窗: 60 minutes
Scans will be compared between running at full strength and running at reduced strength. Participants will rate the acoustic noise using a 5-point Likert scale, where 1= A much louder than B, 2=A slightly louder than B, 3=A comparable to B, 4=A slightly quieter than B, 5=A much quieter than B. A=spiral scans with full gradient strength and B=spiral scans with reduced gradient strength.
次要结局
未报告次要终点