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

Summary

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.

Conditions

• Breast Cancer

Interventions

OTHER

Contrast enhanced breast MRI

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

Sponsors & Collaborators

• Dutch Breast Cancer Screening Organisations

  collaborator UNKNOWN

• Dutch Reference Centre for Screening

  collaborator UNKNOWN

• National Institute for Public Health and the Environment (RIVM)

  collaborator OTHER_GOV

• The Netherlands Cancer Institute

  collaborator OTHER

• University Medical Center Nijmegen

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Hospital Group Twente (ZGT)

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Dutch Cancer Society

  collaborator OTHER

• Pink Ribbon Inc.

  collaborator INDUSTRY

• A Sister's Hope

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• Stichting Kankerpreventie Midden-West

  collaborator UNKNOWN

• Volpara Solutions

  collaborator OTHER

• UMC Utrecht

  lead OTHER

Principal Investigators

• Carla H van Gils, PhD · UMC Utrecht

• Wouter B Veldhuis, MD PhD · UMC Utrecht

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2023-04-30

Completion

2023-04-30

Countries

• Netherlands

Study Locations