Whole-body MR Imaging for Staging Malignant Lymphomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- The primary outcome will be the clinical stage according to WB-MRI findings and according to CT-findings. This clinical stage will be determined according to the Ann Arbor classification system.
研究概览
简要总结
Background:
The malignant lymphomas, Hodgkin´s disease (HD) and non-Hodgkin´s lymphoma (NHL), comprise approximately 5-6% of all malignancies in adults and account for 10% of childhood cancers. Once the diagnosis has been established histologically, extent of disease (staging) and response to therapy will be assessed by means of a computed tomography (CT) scan of the body. The staging at presentation is important for determining prognosis and choice of treatment. Unfortunately, CT is accompanied by a significant amount of radiation exposure which may induce second cancers. This is especially important in childhood, because rapidly dividing cells are more sensitive to radiation induced effects and children will have more years ahead in which cancerous changes might occur. New magnetic resonance imaging (MRI) techniques offer an alternative way for staging and follow-up of cancers, including the malignant lymphomas. Whole-body MRI (WB-MRI) is a radiation-free method which allows imaging of the body with excellent soft tissue contrast in a single examination.
Purpose:
The aim of this study is to examine if WB-MRI can replace CT in staging of patients with a malignant lymphoma.
Design:
This will be a multicenter, prospective, diagnostic cohort study (timeschedule: 36 months). 135 eligible patients will undergo WB-MRI on top of the protocolar imaging routinely done.
Study population:
Patients aged 8 years and older with a histological diagnosis of HD or NHL.
Statistical analysis:
The challenge of this study will be to show non-inferiority of WB-MRI compared to CT in staging malignant lymphoma. Testing of this hypothesis will be one-sided and performed using recently proposed techniques by Lui et al.
Radiation-related risk assessment:
A risk model will be used, based on the BEIR VII report, for modelling the late-term mortality from radiation induced tumors after exposure to ionizing radiation.
Economic evaluation:
Actual costs (from a societal perspective) will be determined for the two diagnostic tests. In case of clinical equivalence and similar costs or cost savings associated with MRI the latter can be considered dominant, obviating further economic evaluation. Otherwise, through modelling of expected long term health impact and associated outcomes such as quality of life and costs the incremental cost effectiveness will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients
- •age: 8 years and older
- •histologically proven Hodgkin's disease or non-Hodgkin's lymphoma
- •patients scheduled for a CT of the body for initial staging
- •participant's parents (participant < 18 years) or the participant (participant >18 years) must willingly give written informed consent prior to the start of the study
- •whole-body MRI has to be performed within 10 days before or after CT, and before therapy has been started.
排除标准
- •patients with a general contraindication for MRI (including cardiovascular pacemakers, claustrophobia)
- •patients who have had a previous malignancy
- •patients who are pregnant or nursing
- •patients in whom therapy has already started after CT and before MRI could be performed
结局指标
主要结局
The primary outcome will be the clinical stage according to WB-MRI findings and according to CT-findings. This clinical stage will be determined according to the Ann Arbor classification system.
时间窗: December 2010
次要结局
- The secondary outcome will be a (subjective) assessment of image quality and presence of artefacts, for both T1-weighted and T2-weighted MR images as well as CT.(December 2010)