A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
To evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.
To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT.
详细描述
This study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (Sensitivity, Specificity, Positive prediction rate, Negative prediction rate) of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years old;
- •Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
- •The expected survival time is over 3 months
- •Voluntarily sign informed consent.
- •Willing and able to follow the research protocol;
- •The subject must be able to lie on the scanning bed for 20 minutes;
排除标准
- •Known allergic history to 68Ga FAPI or its excipients;
- •Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
- •Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
- •pregnant and lactating women;
- •Workers who are exposed to radiation for a long period of time;
- •Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis;
- •Participating in other interventional clinical trials within 1 month before screening;
- •Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;
- •There are other circumstances that the researcher thinks are not suitable for participating in this study;
结局指标
主要结局
Specificity
时间窗: Up to 24 months
Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Negative prediction rate
时间窗: Up to 24 months
Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Sensitivity
时间窗: Up to 24 months
Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Positive prediction rate
时间窗: Up to 24 months
Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
次要结局
未报告次要终点
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University