Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
The number of interval cancers will be compared between the MRI group and the control group
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.
8 years (with an interim analysis every two years; time period between two screening rounds)
Carla H van Gils, PhD
The Netherlands: Ministry of Health, Welfare and Sports