NCT02071706已完成不适用
Clinical Evaluation of an Integrated PET/MRI System
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
- 62
- 试验地点
- 2
- 主要终点
- Number Usable PET/MRI Image Sets
研究概览
简要总结
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject must have a clinical indication for a PET/CT exam
- •Subject must be at least eighteen (18) years of age; and
- •Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging; and
- •Subject must be able to hear and understand instructions without assistive devices; and
- •Subject must provide written informed consent; and
- •Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
- •Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
- •Subject must be able to participate in a PET/MR imaging session within 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.
排除标准
- •Subjects who have any axial diameter larger than 55 cm; or
- •Subjects with a weight greater than 227 kgs; or
- •Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator; or
- •Subjects that have implants with MR Unsafe labeling; or
- •Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol ; or
- •Subjects who have a contraindication to MRI according to the screening policy of the participating site
研究组 & 干预措施
Single-Arm PET/MRI
Other
Single-group evaluation of PET/MRI for diagnostic quality of image
干预措施: PET/MRI system (Device)
结局指标
主要结局
Number Usable PET/MRI Image Sets
时间窗: 1 day
The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale
Number of Diagnostic Quality Images
时间窗: 1 day
Number of images sets deemed diagnostic quality by the investigator
次要结局
未报告次要终点
研究者
研究点 (2)
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