Comparison of Whole-body MRI, Circulating DNA and PET-CT in Staging, Prognosis, and Treatment Response in Patients with Diffuse Large Cell B Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of whole-body MRI in staging of DLBCL
研究概览
简要总结
The aim of the study is to compare the diagnostic performance of whole-body MRI scan, positron emission tomography + CT, and circulating tumor DNA in patients with hematologic malignancy called diffuse large cell B lymphoma (DLBCL) in staging and restaging, and prognosis.
详细描述
Patients newly diagnosed with DLBCL or patients with relapsed DLBCL who consent to participate in this study will apart from standard staging and restaging examination with PET/CT undergo whole-body MRI (wbMRI). From blood samples, the level of circulating tumor DNA (ctDNA) fragments will be estimated. These procedures will be repeated during restaging after primary treatment. The diagnostic accuracy of wbMRI in initial staging and restaging will be compared with PET/CT as the gold standard. Circulating tumor DNA levels will be compared at baseline with staging from PET/CT. The change in levels of ctDNA will be compared with the treatement response assessed by PET/CT. All three methods will be used as prognostic indicators.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •performance status according to the Eastern Cooperative Oncology Group between 0 and 3
- •satisfactory clinical condition to participate in this study
- •adequate hematologic and renal functions
- •no contraindications to MRI
- •recent or planned PET/CT at the institution
- •informed consent to participate.
排除标准
- •history of indolent lymphoma
- •anti-lymphoma treatment initiated before PET/CT or wbMRI
- •central nervous system lymphoma
结局指标
主要结局
Diagnostic accuracy of whole-body MRI in staging of DLBCL
时间窗: at baseline
Comparison of diagnostic accuracy of whole-body MRI in staging of DLBCL in newly diagnosed adult patients before treatment compared to PET/CT as the gold standard
次要结局
- Diagnostic value of MRI sequences(At baseline)
- Assessment of therapeutic response(after completion of first-line treatment, on average 6 months)
研究者
Lukas Lambert
prof. MD. Ph.D.
Charles University, Czech Republic