Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial

Summary

Women with extremely dense breasts (nearly all glandular and connective tissue, little fatty tissue) have a 3-6 times higher risk of breast cancer than women with very low breast density. Moreover, due to the masking effect of the dense tissue, any breast tumours present are more difficult to detect in these women. With the results of the DENSE trial, the investigators showed that among women with extremely dense breasts, a combination of MRI and mammography could detect tumours earlier than mammography only. As the implementation of MRI in the screening program induces considerable costs and capacity requirements, the Dutch Ministry of Health would like to investigate whether cheaper and acceptable alternatives can be implemented more easily. In the DENSE-2 study, proposed here, we will investigate contrast-enhanced mammography and an abbreviated form of MRI as alternatives, in a large-scale randomized trial, within the current population-based screening program.

Conditions

• Breast Cancer

Interventions

DIAGNOSTIC_TEST

Contrast-enhanced mammography (CEM)

This intervention group receives supplemental screening with CEM after a negative screening result within the Dutch National Breast Cancer Screening program

DIAGNOSTIC_TEST

Abbreviated MRI (AB-MRI)

This intervention group receives supplemental screening with AB-MRI after a negative screening result within the Dutch National Breast Cancer Screening program

Sponsors & Collaborators

• University Medical Center Groningen

  collaborator OTHER

• Ziekenhuisgroep Twente

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Zuyderland Medical Centre

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Jeroen Bosch Hospital

  collaborator UNKNOWN

• Erasmus Medical Center

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Antoni van Leeuwenhoek Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Bevolkingsonderzoek Nederland

  collaborator UNKNOWN

• Borstkankervereniging Nederland

  collaborator UNKNOWN

• C.H. van Gils

  lead OTHER

Principal Investigators

• Carla van Gils, Prof. · UMC Utrecht

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

49 Years

Max Age

72 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-11

Primary Completion

2029-12-31

Completion

2031-09-01

Countries

• Netherlands

Study Locations