Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- SUVmax
研究概览
简要总结
Chemokine receptor CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM and lymphoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM and lymphoma.
详细描述
Multiple myeloma:
Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The Durie and Salmon and ISS clinical staging system have been well-accepted as a practical way to evaluate MM tumor burden nowadays. But it is difficult to assess the accurate tumor involvement because of the significant heterogeneity characterizing this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome. New imaging modalities such as 18F-FDG PET/CT has been used to improve the efficacy of this system in assessing the extent and severity of MM, but the diagnostic accuracy of 18F-FDG PET/CT decreased in lower proliferative MM cells and inflammation. Recent studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM.
Lymphoma:
Lymphoma is a frequent cancer with high CXCR4 expression. According to the previous studies, 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis,differentiation and pretherapeutic evaluation of CXCR4 expression in lymphoma.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
68Ga-Pentixafor, PET/CT
Inject 68Ga-Pentixafor and then perform PET/CT scan.
干预措施: 68Ga-Pentixafor (Drug)
结局指标
主要结局
SUVmax
时间窗: through study completion, an average of 2 years
SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the L3 vertebra is defined as the general marrow activity on the condition that there is no focally hypermetabolic disease.
次要结局
- Diagnostic value(through study completion, an average of 2 years)
- Incidence of emergency events during the study(through study completion, an average of 2 years)
- Tumor burden assessement(through study completion, an average of 2 years)
- Diagnostic value in special type of multiple myeloma(through study completion, an average of 2 years)
- CXCR4 expression and SUV(through study completion, an average of 2 years)
- Overall Survival(1 year and 5 years after been diagnosed)
- Disease Free Survival(1 year and 5 years after been diagnosed)
- Disease Specific Survival(1 year and 5 years after been diagnosed)
