Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT
研究概览
简要总结
Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells. Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation of extent of disease and response to therapy than the current standard of care, F-18 FDG PET/CT.
The main purpose of the study is to investigate a new PET/CT imaging probe for detection and follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability, pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to rituximab-based treatment in CD20-positive B-cell NHL
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have a diagnosis of CD20-positive B-cell NHL and a staging 18F FDG PET/CT prior to the 64Cu-DOTA-Rituximab PET/CT
- •Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them
- •Patients must be scheduled for rituximab-based therapy
- •Patients must be older than 18-year-old
排除标准
- •Patients who cannot complete a PET/CT scan
- •Pregnant women
- •Patients participating in other research protocols will be excluded from this study
研究组 & 干预措施
64Cu-DOTA
Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes.
干预措施: Cu-64 Rituximab (Drug)
结局指标
主要结局
Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT
时间窗: baseline and 6 weeks
Pre- and post-treatment tumor SUVmax value on the 64Cu-DOTA-Rituximab PET/CT and 18F FDG PET/CT, and resulting EORTC-based classification of patients as responding or not responding to treatment.
次要结局
未报告次要终点
研究者
Sanjiv Sam Gambhir
Professor of Radiology
Stanford University