Clinical Evaluation Of MP26 Features in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Diagnostic Image Quality
研究概览
简要总结
The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. The images and summary data from this study are intended for use in regulatory submission.
详细描述
Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population.
Secondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites.
Safety Objective(s): To collect information about safety events and device issues.
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
- 否
入选标准
- •Are adults (aged 18 or older);
- •Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required);
- •Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
- •Can hear without assistive devices and have necessary mental capacity to follow study instructions;
- •Are willing and able to provide written informed consent;
- •Are considered eligible for MRI and PET exams, according to site institutional safety policies.
排除标准
- •Were previously enrolled in the study;
- •If female, are pregnant or of undetermined pregnancy status;
- •Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
- •Have implants or attached medical devices that could be unsafe for MRI;
- •Have medical conditions or require urgent care that could make it unsafe to participate
研究组 & 干预措施
PET/MR ZTE MRAC
PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.
Zero Echo Time (ZTE) scan for head attenuation
干预措施: Zero Echo Time (ZTE) scan for head attenuation (Device)
PET/MR Q Static (Q. MRAC)
Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.
PET/MR Q Static (Q. MRAC)
干预措施: Q.Static (Q. MRAC) for respiratory motion correction (Device)
结局指标
主要结局
Diagnostic Image Quality
时间窗: through study completion, an average of 2 months
scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent
次要结局
- Determination of Diagnostic Acceptability(through study completion, an average of 2 months)
- Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score(through study completion, an average of 2 months)
- Number of Participants Reporting "Yes" On All Binary Performance Scale Questions(through study completion, an average of 2 months)