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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
40,373
Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Hospital Group Twente (ZGT)
Almelo, Netherlands
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
VU University Medical Center
Amsterdam, Netherlands
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.
Time frame: 8 years (with an interim analysis every two years; time period between two screening rounds)
The number of MRI screen-detected tumors will be determined
The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.
Time frame: 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
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.
Time frame: 8 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
The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.
Time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)
The positive predictive value (and the amount of false-positive diagnoses) of MRI will be determined using the histological diagnosis as the reference test
The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.
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Albert Schweitzer Hospital
Dordrecht, Netherlands
Hospital Group Twente (ZGT)
Hengelo, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)
The number of biopsies per positive MRI will be determined
The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.
Time frame: 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
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.
Time frame: 8 years
The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program
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.
Time frame: 8 years
The impact of MRI screening on quality of life will be assessed using standardized and validated questionnaires
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.
Time frame: 8 years