Comparison of 68Ga-pentixather and 68Ga-pentixafor PET/CT in Patients With Multiple Myeloma
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PET-positive diffuse bone marrow involvement
研究概览
简要总结
Chemokine receptor-4 (CXCR4) is overexpressed in multiple myeloma (MM) cells. 68Ga-pentixafor is a radio-labled tracer for CXCR4 . 68Ga-pentixafor PET/CT has shown good diagnostic performance in MM. But an exchange of Ga3+ by Lu3+ or Y3+ will lead to a significant loss of CXCR4 affinity. Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.
详细描述
Multiple myeloma (MM) is a malignant plasma cell disorder which is characterized by clonal proliferation of plasma cell in bone marrow microenvironment. Chemokine receptor-4 (CXCR4) is overexpressed in MM cells, and has been identified as a potential therapy target. 68Ga-pentixafor is a radiolabeled ligand with high affinity for CXCR4. 68Ga-pentixafor PET/CT has been reported with better diagnostic performance than 18F-FDG PET/CT. However, considering both diagnostic and therapeutic applications, an exchange of Ga3+ by other M3+ ions (Lu or Y) will lead to a significant loss of CXCR4 affinity. Thus, pentixather was developed as the precursor of 177Lu-pentixather or 90Y-pentixather, which can be used in CXCR4-targeted peptide receptor radionuclide therapy (PRRT). Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.
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
- •Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission
- •Signed written consent
排除标准
- •breastfeeding
- •known allergy against pentixather or pentixafor
- •any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
研究组 & 干预措施
68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan
Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval
干预措施: 68Ga-Pentixather (Drug)
68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan
Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval
干预措施: 68Ga-Pentixafor (Drug)
结局指标
主要结局
PET-positive diffuse bone marrow involvement
时间窗: through study completion, an average of 2 years
Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
PET-positive focal bone marrow lesions
时间窗: through study completion, an average of 2 years
Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
PET-positive extramedullary lesions
时间窗: through study completion, an average of 2 years
Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
Metabolic parameter
时间窗: through study completion, an average of 2 years
Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
次要结局
- CXCR4 expression in biopsies and metabolic parameters in PET(through study completion, an average of 2 years)
- Adverse effects(through study completion, an average of 2 years)
- Tumor burden assessment(through study completion, an average of 2 years)
- Follow-up assessment(through study completion, an average of 2 years)