Validation of 3D Synthetic MRI for Neuroimaging - Prospective, Multicenter, Multireader Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 12
- 主要终点
- Sensitivity of Pathological Findings (Full Analysis Set)
研究概览
简要总结
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
详细描述
This study is a prospective, blinded, multi-center, multi-reader clinical study that is statistically powered for demonstrating non-inferiority of synthetic 3D MR images compared to conventional MR images with respect to sensitivity and specificity of pathological findings.
The study consists of three parts:
- Clinical MR acquisition,
- Synthetic MR post-processing
- Blinded image evaluation of conventional and synthetic images for each subject.
The study will enroll eligible subjects with an already scheduled brain MRI and also healthy volunteers, that meet applicable site MR safety criteria. The routine MRI scan will include approximately 5-20 minutes extra time for the additional images to be taken. This time will be added to the length of the scheduled scan. It is only the time in the MRI scanner that will differ from standard procedures, no other examinations will be performed.
The study consists of one visit, without additional follow-up.
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
盲法说明
For each subject, conventional and synthetic images will be assessed by blinded, experienced neuroradiologists who will assess the images with regards to radiological findings, image quality, legibility of anatomical structures, and artifacts. The readings will be separated into two reading sessions with a 4-week memory-washout period.
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender, aged 0-99 years
- •Subject scheduled for MRI of the brain OR Healthy control with passed screening form
- •Subject suitable for MRI as judged by investigator
- •Subject agrees to 5-20 min extra MRI scan time
- •Subject able to understand written and verbal information in English or Spanish
- •Provision of informed consent (and assent if applicable)
排除标准
- •Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site
- •Have severe trauma, disability or pre-existing pathology that is expected to interfere with normal conduct of MRI scanning or complete scanning of the brain
- •Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician investigator, would prevent safe participation in the study
- •Adult subjects (aged 18-99 years) in need of anesthesia during MRI scanning
- •Pregnancy at time of enrollment determined according to the clinic's MR Safety Screening policy
- •Previous enrollment in this investigation
结局指标
主要结局
Sensitivity of Pathological Findings (Full Analysis Set)
时间窗: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Specificity of Pathological Findings (Full Analysis Set)
时间窗: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
次要结局
- Classification of Pathological Findings(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)
- Sensitivity (Adult Population)(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)
- Selectivity (Adult Population)(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)
- Classification of Pathological Findings (Adult Population)(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)
- Sensitivity (Pediatric Population)(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)
- Selectivity (Pediatric Population)(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)
- Classification of Pathological Findings (Pediatric Population)(Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8)