Whole Body MRI With DWI for Monitoring Patients Treated for Testicular Cancer Stage II-III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- MRI vs CT for testicular cancer
研究概览
简要总结
Testicular cancer (TC) affects approx. 1% of Danish men and is the most common cancer in men aged 15-35 years. It is the most curable solid cancer type with a 5-year survival rate of 90-95%. Staging and follow-up of these patients involve 5-10 CT scans of each patient, imposing a significant radiation burden: Approx. 3-5 of the 300 Danish patients presenting with TC each year are expected to develop a radiation-induced secondary cancer, half of which are expected to be fatal.
MRI is rapidly developing and new WB-MRI can cover large parts of the body in a clinically realistic scan time. With this development, it is within reach to nearly eliminate the radiation burden by substituting the large amount of CT scans with MRI scans in TC. MRI is without any known risk of long-term side effects. Despite this, limited data exist on MRI used in follow-up of TC.
At Aarhus University Hospital, we introduced MRI for the follow-up of TC stage I in 2008. We now want to evaluate the results of in this unique cohort of patients and evaluate in a prospective trial if the newest WB-MRI techniques can replace CT in patients with TC stage II-IV. To the best of our knowledge, no study has investigated how much it is possible to reduce the MRI scan time in patients with TC in order to develop a clinically realistic scan time while still maintaining an acceptable uncompromised diagnostic accuracy.
The overall aim of this study is to reduce the risk of radiation-induced secondary cancers in patients operated diagnosed with TC by replacing CT as a follow-up imaging method with non-ionizing WB-MRI including DWI. We have these specific aims:
- To study the ability of WB-MRI with DWI to replace standard CT in TC stage II-III patients in a prospective non-inferiority study.
- To evaluate if it is possible to reduce scan time in the WB-MRI protocols in the TC stage II-III group while maintaining sufficient diagnostic accuracy in order to improve clinical application of the techniques.
详细描述
AIMS AND HYPOTHESES
The overall aim of this study is to reduce the risk of radiation-induced secondary cancers in patients operated for testicular cancer (TC) by replacing computed tomography (CT) as a follow-up imaging method with non-ionizing whole body magnetic resonance imaging (WB-MRI) including diffusion weighted imaging (DWI). Under the hypotheses that MRI can detect relapse in stage I patients, that MRI is not inferior to CT for diagnosing and monitoring metastatic disease in stage II-III patients, and that the scan time of MRI with DWI can be reduced in order to facilitate the clinical and practical feasibility, the trial has two specific aims leading to two substudies:
A) To study the ability of WB-MRI with DWI to replace standard CT in TC stage II-III patients in a prospective, non-inferiority study.
B) To evaluate if scan time in the WB-MRI can be significantly reduced in the TC stage II-III group by using multiband DWI technique and by evaluating the minimum necessary image quality while maintaining sufficient diagnostic accuracy in order to improve clinical applicability of the technique.
BACKGROUND TC affects approximately 1% of Danish men with 301 new cases in 2015 and is the most common cancer in men aged 15-35 years. It is the most curable solid cancer type with a 5-year survival rate of 90-95%; In 2013 97% of Danish patients were alive two years after diagnosis. According to Danish and European guidelines, staging and follow-up of these patients involve 5-10 CT scans of each patient, imposing a significant radiation burden. Based on the risk estimates of BEIR VII and the Danish guidelines, approx. 3-5 of the 300 Danish patients presenting with TC each year are expected to develop a radiation-induced secondary cancer in their remaining life time, half of which are expected to be fatal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed TC stage II-III disease or
- •Previously TC stage I disease with new spread of disease during surveillance
排除标准
- •Age < 18 years
- •Claustrophobia or unable to fit inside the bore of the MRI-scanner
- •Foreign metal objects contraindicating a 1.5T MRI including pacemaker
结局指标
主要结局
MRI vs CT for testicular cancer
时间窗: Aprox. 1 month after treatment
Non-inferiority design
次要结局
- Optimization of MRI scan duration(Aprox. 1 month after treatment)
研究者
Solveig Kärk Abildtrup Larsen
MD, PhD student
Aarhus University Hospital