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Completed

NCT Number: NCT01315015

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contrast enhanced breast MRI

Other

Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.

Other names: MR Mammography

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. The number of MRI screen-detected tumors will be determined

    Time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)

    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.

  2. Tumor size, stage and grade distributions, including their histological and molecular subtypes, diagnosed in both study groups will be compared

    Time frame: 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.

  3. The referral rate in the MRI study group will be determined

    Time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)

    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.

  4. The positive predictive value (and the amount of false-positive diagnoses) of MRI will be determined using the histological diagnosis as the reference test

    Time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)

    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.

  5. The number of biopsies per positive MRI will be determined

    Time frame: 6 years (with an interim analysis every two years; time period between two screening rounds)

    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.

  6. The mortality rate in the MRI group will be compared with the control group using the MISCAN computer simulation program

    Time frame: 8 years

    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.

  7. The cost-effectiveness of MRI will be estimated using the MISCAN computer simulation program

    Time frame: 8 years

    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. The impact of MRI screening on quality of life will be assessed using standardized and validated questionnaires

    Time frame: 8 years

    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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • A Sister's Hope
  • Albert Schweitzer Hospital
  • Amsterdam UMC, location VUmc
  • Bayer
  • Dutch Breast Cancer Screening Organisations
  • Dutch Cancer Society
  • Dutch Reference Centre for Screening
  • Hospital Group Twente (ZGT)
  • Jeroen Bosch Ziekenhuis
  • Maastricht University Medical Center
  • National Institute for Public Health and the Environment (RIVM)
  • Pink Ribbon Inc.
  • Stichting Kankerpreventie Midden-West
  • The Netherlands Cancer Institute
  • University Medical Center Nijmegen
  • Volpara Solutions
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Important dates

Study start
2011
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2011
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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