Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 14000
Summary
- Conditions
- Breast Cancer
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 50 years and 75 years
- Gender
- Only males
Description
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 Net...
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).
Tracking Information
- NCT #
- NCT01315015
- Collaborators
- Dutch Breast Cancer Screening Organisations
- Dutch Reference Centre for Screening
- National Institute for Public Health and the Environment (RIVM)
- The Netherlands Cancer Institute
- Volpara Solutions
- University Medical Center Nijmegen
- Stichting Kankerpreventie Midden-West
- Jeroen Bosch Ziekenhuis
- A Sister's Hope
- Bayer
- Dutch Cancer Society
- Albert Schweitzer Hospital
- Hospital Group Twente (ZGT)
- VU University Medical Center
- Pink Ribbon Inc.
- Maastricht University Medical Center
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Principal Investigator: Carla H van Gils, PhD UMC Utrecht Principal Investigator: Wouter B Veldhuis, MD PhD UMC Utrecht
Get Well Soon