Early Evaluation of the Response of Large B Cell Non Hodgkin's Lymphoma to Chemotherapy by Positron Emission Tomography Coupled With Computed Tomography (PET/CT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Disease free survival at 2 years
研究概览
简要总结
Patients affected with non-Hodgkin's large B-cell lymphoma are treated by chemotherapy. The evaluation of the response to this treatment is made by Positron Emission Tomography (PET/CT) in many centres where this technology is available. Presently PET scans and CT scans are being performed before treatment, after 4 cycles of chemotherapy and a few months after the end of treatment.
The goal of this study is to determine if it is possible to evaluate the efficiency of chemotherapy treatments after one cycle of treatment instead of waiting after 4 cycles, using a new scanner that combines PET and CT modalities. Data available from studies on these combined exams suggest that PET/CT helps to rapidly evaluate the response of the chemotherapy treatment. We also want to verify if some pathological characteristics measured from tumor cells will enable doctors to predict in advance the response to treatment.
详细描述
Participation in this study involves 4 PET/CT exams, which occur before the treatments start, after the first cycle of chemotherapy, after 4 cycles of chemotherapy and then 12 weeks after the end of the treatments. The only additional test performed in this study compared to the regular follow-up of patients that are not in this study is the PET/CT exam after the first cycle. Your participation in this study will not affect treatment since the results of the first PET/CT test will not be communicated. All other tests results will be available in the medical record.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed large B cells non Hodgkin's lymphoma, CD20 positive
- •Chemotherapy treatments planned (R-CHOP) but not started
排除标准
- •Pregnancy (determined by urinary β-HCG and blood test)
- •Patients younger than 18 years
- •Unable to tolerate the procedure (30 minutes laying down on the back)
- •No chemotherapy treatment planned secondary to the patient's health performance
- •Previous lymphoma that has been treated with chemotherapy with the exception of stade I lymphoma treated only with radiotherapy.
- •All lymphoma other than large cell Non Hodgkin's lymphoma
结局指标
主要结局
Disease free survival at 2 years
次要结局
未报告次要终点