Prospective Clinical Study of 18F-Pentixafor PET Imaging in Hematologic Malignancies
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 aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.
详细描述
18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-80 years old, both sexes, with behavioral capacity;
- •patients with suspected or confirmed hematological malignancies;
- •18F-FDG PET or other imaging examinations should be performed according to the treatment plan;
- •For suspected patients, biopsy or needle biopsy is expected to obtain pathological results;
- •Can provide informed consent, can understand and comply with the requirements of the study.
排除标准
- •pregnant and lactating women;
- •patients with fear or radiophobia, or with mental disorder or primary affective disorder;
- •received ionizing radiation outside the scope of this study for clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv;
- •received investigational drugs or devices of uncertain efficacy or safety within 1 month;
- •Any condition that the chairpersons of the study consider that any link related to the study may cause harm or have potential harm.
研究组 & 干预措施
18F-Pentixafor PET/CT in Hematologic Malignancies
Each patient receive a single intravenous injection of 18F-Pentixafor 55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection.
干预措施: 18F-Pentixafor (Drug)
结局指标
主要结局
Diagnostic efficacy
时间窗: through study completion, an average of 1.5 year
Sensitivity, specificity, positive and negative predictive value of 18F-Pentixafor PET/CT and PET/MR Imaging in hematological malignancies.
次要结局
- 18F-Pentixafor PET performence compared with 18F-FDG(up to 24 months)
- Deauville Score(through study completion, 3-4 years)