Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- PET Image of the Brain
研究概览
简要总结
The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.
The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form).
- •Ability to sit still in the head-only PET scanner for 15 minutes.
- •Are scheduled to receive a regular brain PET scan as part of clinical routine.
- •Male and Female patients 18 years to 80 years of age.
排除标准
- •Contraindications to PET examination,
- •Patient height smaller than 160 cm or taller than 200 cm,
- •Patient weight more than 120 kg,
- •Patient cannot sit upright for at least 15 minutes,
- •Metal implants in the head,
- •Pregnant or Breastfeeding women,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
结局指标
主要结局
PET Image of the Brain
时间窗: 1 day
The primary outcome will be a PET image of the brain for each participant taken on NeuroLF. It will be compared against the image taken by the conventional PET machine by a trained physician and judged by whether it could be used for diagnosis and further analysis.
次要结局
- Ease of Placement (Usability)(1 day)
- Usage of accessories for patient placement (Usability)(1 day)