Clinical Investigation of CD38-Targeted Molecular Imaging Probes in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
The objective of the study is to construct a noninvasive approach CD38 targeted PET/CT to detect tumor lesions in patients with Multiple Myeloma and to compare with FDG PET/CT.
详细描述
CD38 targeting PET radiotracer is promising as an excellent imaging agent applicable to Multiple Myeloma. In this research, subjects with Multiple Myeloma or highly suspected recurrence detection underwent contemporaneous CD38 PET/CT and standard-of-care imaging (FDG PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and FDG PET/CT were recorded by visual interpretation. The diagnostic accuracy of CD38 PET/CT was calculated and compared to standard-of-care imaging.
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
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
- •Adult patients (aged 18 years or older);
- •Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of Multiple Myeloma (supporting evidence may include MRI, CT, tumor markers, and pathology report);
- •Patients who had scheduled both standard-of-care imaging (FDG PET/CT) and cd38 PET/CT scans;
- •Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
排除标准
- •The inability or unwillingness of the research participant or legal representative to provide written informed consent.
结局指标
主要结局
Diagnostic efficacy
时间窗: 3 year
The sensitivity, specificity, and accuracy of standard-of-care imaging (FDG PET/CT) and CD38 PET/CT were calculated and compared to evaluate the diagnostic accuracy.
次要结局
- Number of lesions(3 year)
- SUV(3 year)
研究者
Wei Fu
Department of Nuclear Medicine
Guilin Medical University, China