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ACTIVE NOT RECRUITING
NCT06059300
NA

Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

50 Years - 72 Years

Study Type

INTERVENTIONAL

Enrollment

18200

Start Date

2023-07-17

Completion Date

2028-07-01

Last Updated

2025-07-29

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Digital Breast Tomosynthesis

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

Locations (1)

Bevolkingsonderzoek Nederland

Utrecht, Netherlands