Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program

Summary

Digital breast tomosynthesis (DBT) creates a digital pseudo- three-dimensional image of the breast similar to mammography. This gives the screening radiologist more information about a possible abnormality. As a result, breast cancer can be found earlier, but more women might need to be recalled.

In the STREAM study, the aim is to identify the impact of DBT on the screen-detected cancer and recall rates, and on interval and advanced cancer rates in 18,200 women after two rounds of screening. For comparison, a control group of about 86,400 women will be selected from the database of the national screening program. Women, screening radiographers, and screening radiologists will be asked whether they find this new screening technique acceptable. Furthermore, the optimal strategy for screening radiologists to read the DBT images will be identified and the cost-effectiveness of screening with DBT will be determined. The images and data will be stored in a database for future research.

Expected outcome:

As a result of this project, the researchers will have shown if breast cancer screening with DBT in the Netherlands should be implemented or not. It will also be demonstrated, were it to be introduced, how it should be implemented, having addressed all the remaining questions, and having found the optimal DBT workflow specifically for a high-volume population-based screening program.

Conditions

• Breast Cancer Screening

Interventions

DIAGNOSTIC_TEST

Digital Breast Tomosynthesis

Screening with Digital Breast Tomosynthesis instead of Digital Mammography, for two screening rounds

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• LRCB Dutch Expert Centre for Screening

  collaborator UNKNOWN

• Dutch Breast Cancer Association

  collaborator UNKNOWN

• University of Sydney

  collaborator OTHER

• Hologic B.V.

  collaborator UNKNOWN

• Volpara Health Technologies Ltd

  collaborator UNKNOWN

• Lunit Inc.

  collaborator INDUSTRY

• Screenpoint Medical BV

  collaborator UNKNOWN

• Sectra Benelux

  collaborator UNKNOWN

• iCAD

  collaborator UNKNOWN

• Dutch Foundation of Population Screening

  collaborator UNKNOWN

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Mireille Broeders, Prof. · Radboud University Medical Center

• Ioannis Sechopoulos, Prof. · Radboud University Medical Center

• Nicolien van Ravesteyn, PhD · Erasmus Medical Center

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

72 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-17

Primary Completion

2027-12-31

Completion

2028-07-01

Countries

• Netherlands

Study Locations