Whole Body Functional and Anatomical MRI: Accuracy in Staging and Treatment Response Monitoring in Adolescent Hodgkin's Lymphoma Compared to Conventional Multimodality Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The per site sensitivity and specificity of MRI for both nodal and extranodal sites and concordance in final disease stage with the multi-modality reference standard
研究概览
简要总结
Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an extended MRI scan.
详细描述
The trial will be a single centre cohort study in patients newly diagnosed with Hodgkin's lymphoma undergoing disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo advanced anatomical and functional MRI sequences.
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
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 to 20 years (inclusive) with participant and parent/guardian informed consent
- •Histologically confirmed first presentation of Hodgkin's Lymphoma
- •Either entered into the Euronet PHL-C1 trial or LP1 trials OR not formally entered into the Euronet trials but treated on the chemotherapy regimens of the Euronet trials for classical and lymphocyte predominant Hodgkin Lymphoma
排除标准
- •Contraindications to MRI (e.g. pacemaker)
- •Previous malignancy or previous chemotherapy or radiotherapy treatment for malignancy
- •Pregnancy or nursing
结局指标
主要结局
The per site sensitivity and specificity of MRI for both nodal and extranodal sites and concordance in final disease stage with the multi-modality reference standard
时间窗: The recruited patients to be followed up for 1 year
次要结局
- Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease(The recruited patients to be followed up for 1 year)
- The number of correct patient classifications into therapy responders and non-responders by MRI compared to the multi modality reference(The recruited patients to be followed up for 1 year)
- Inter observer agreement for MRI between reporting radiologists (on site and off site). responders by MRI compared to the multi modality reference(The recruited patients to be followed up for 1 year)
- Sensitivity, specificity of qualitative assessment of Minimum intensity projection (MIP) inverted high B value datasets(The recruited patients to be followed up for 1 year)
- Simulated effect of MRI on clinical management via external oncologic review(The recruited patients to be followed up for 1 year)