Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change of physician's diagnostic confidence
研究概览
简要总结
The main purpose is to evaluate initial clinical experiences and to explore whether the Vision.X system yields improved image quality and diagnostic performance compared to Vision 600.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Inform Consent to participating.
- •18 to 85 years of age
- •Willing and able to comply with the requirements of the study, as judged by the investigator
排除标准
- •Women in pregnancy
- •Patients unable to lie still for the duration of the examination
结局指标
主要结局
change of physician's diagnostic confidence
时间窗: through study completion , an average of 1 year
The primary outcome will be image quality assessed on the two compared PET systems, namely Vision and Vision X. For the all PET scans, three independent, blinded physicians will evaluate the scans and establish diagnoses. They will assess the following quality criteria using 5-point Likert scales: * Overall Image Quality: 1 = poor, 5 = excellent, * Image Noise: 1 = excessive noise, 5 = no perceptible noise, Image quality is associated with physician's diagnostic confidence and with the ability to detect smaller lesions that can lead to more accurate staging of diseases, particularly in oncology and neurology. This enhanced staging can influence treatment decisions, allowing healthcare professionals to tailor interventions based on a more precise understanding of the extent and location of the disease.
次要结局
- lowering of the radiotracer activity(through study completion , an average of 1 year)
研究者
Valentina Garibotto
Director of the Division of Nuclear Medicine and Molecular imaging, associate professor
University Hospital, Geneva