Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 40,373
- 试验地点
- 9
- 主要终点
- The number of interval cancers will be compared between the MRI group and the control group
研究概览
简要总结
The purpose of this study is to determine the cost-effectiveness of biennial screening with mammography and MRI compared to mammography alone in women aged 50-75 years and who show > 75% mammographic density.
详细描述
Women with very high mammographic density have a four to six fold higher breast cancer risk than women with low mammographic density. At the same time, the sensitivity of mammography is seriously impaired in women with high mammographic density, leading to many missed cases. Nevertheless, in the Netherlands this high risk group is currently screened between the age of 50 and 75 years with mammography only. MRI is likely to lead to better detection of breast tumors in women with high mammographic density, because it has a much higher sensitivity than mammography. The DENSE trial investigates the additional value of MRI for breast cancer screening in this risk group. Participants with extremely dense breasts (ACR4) and a negative mammogram are randomized to 'additional MRI' (n=7,237) versus 'current practice' (n=28,948).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Dutch breast cancer screening participants, aged 50-75 years
- •> 75% mammographic density
- •Negative mammographic examination (BIRADS 1 or 2)
排除标准
- •Contraindications for MRI
- •The presence of intracorporeal metals
- •Adverse reaction to a (gadolinium-based) contrast agent in the past
- •Severely impaired renal function (GFR < 40 mL/min)
- •Pregnant or lactating women
- •Claustrophobia
- •Adiposity (> 150 kg)
结局指标
主要结局
The number of interval cancers will be compared between the MRI group and the control group
时间窗: 8 years (with an interim analysis every two years; time period between two screening rounds)
The intervention will be carried out for six years, i.e. 3 screening rounds. Given a two year recruitment period, the total study time will be 8 years.
次要结局
- The positive predictive value (and the amount of false-positive diagnoses) of MRI will be determined using the histological diagnosis as the reference test(6 years (with an interim analysis every two years; time period between two screening rounds))
- Tumor size, stage and grade distributions, including their histological and molecular subtypes, diagnosed in both study groups will be compared(8 years (with an interim analysis every two years; time period between two screening rounds))
- The number of biopsies per positive MRI will be determined(6 years (with an interim analysis every two years; time period between two screening rounds))
- The referral rate in the MRI study group will be determined(6 years (with an interim analysis every two years; time period between two screening rounds))
- The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program(8 years)
- The impact of MRI screening on quality of life will be assessed using standardized and validated questionnaires(8 years)
- The number of MRI screen-detected tumors will be determined(6 years (with an interim analysis every two years; time period between two screening rounds))
- The mortality rate in the MRI group will be compared with the control group using the MISCAN computer simulation program(8 years)
研究者
C.H. van Gils
Professor of Clinical Epidemiology of Cancer
UMC Utrecht