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Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial

Phase 4
49 Years
75 Years
Open (Enrolling by invite only)
Breast Cancer

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Trial Information

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
practice' (n=28,948).

Inclusion Criteria:

- Dutch breast cancer screening participants, aged 50-75 years

- > 75% mammographic density

- Negative mammographic examination (BIRADS 1 or 2)

Exclusion Criteria:

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

The number of interval cancers will be compared between the MRI group and the control group

Outcome Description:

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.

Outcome Time Frame:

8 years (with an interim analysis every two years; time period between two screening rounds)

Safety Issue:


Principal Investigator

Carla H van Gils, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


The Netherlands: Ministry of Health, Welfare and Sports

Study ID:




Start Date:

November 2011

Completion Date:

December 2019

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Breast neoplasm
  • Magnetic Resonance Imaging
  • Breast density
  • Early detection of cancer
  • Cancer screening test
  • Secondary prevention
  • Breast Neoplasms