Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program

NCT06059300 | Active Not Recruiting

• 3 other identifiers: 114374137105550402130002
• Study Type: interventional
• Target: 18,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Digital breast tomosynthesis; Acceptability; Reading strategy; Artificial intelligence; Cost-effectiveness; Recall rate; Detection rate; Advanced cancer detection rate; Interval cancer rate

Outcome Measures

Primary Outcomes (1)

• The effect of DBT screening on breast cancers diagnosed at an advanced stage at screening or in between rounds of screening. (detection rate of stage II+ cancers per 1000 screens and interval cancer rate per 1000 screens)

  The outcome will be compared to the control group (DM)

  5 years

Secondary Outcomes (5)

• Attendance rate (percentage out of all women invited)

  5 years

• Recall (percentage out of all women screened)

  5 years

• Cancer detection rate for breast cancer, both invasive and in situ, overall and for cancers stage II or higher (stage II+; per 1000 screened)

  5 years

• Positive predictive value for recall (percentage of cancers detected among recalled women)

  5 years

• Interval cancer rates (breast cancer detected clinically in the first, second, or third year after a negative screening examination.

  5 years

Study Arms (1)

Intervention group

EXPERIMENTAL

18200 participants who will be screened with tomosynthesis instead of digital mammography. All participants will be asked to participate in the study for 2 screening rounds. The number of participants for the second round will be less, due to drop-outs.

Diagnostic Test: Digital Breast Tomosynthesis

Interventions

Digital Breast Tomosynthesis DIAGNOSTIC_TEST

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

Intervention group

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are invited to participate to the Dutch Breast Cancer Screening program in the age group 50-72 years..

You may not qualify if:

• Disabled women
• Women who are wheelchair bound

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Erasmus Medical Center: collaborator
• UMC Utrecht: collaborator
• LRCB Dutch Expert Centre for Screening: collaborator
• Dutch Breast Cancer Association: collaborator
• University of Sydney: collaborator
• Hologic B.V.: collaborator
• Volpara Health Technologies Ltd: collaborator
• Lunit Inc.: collaborator
• Screenpoint Medical BV: collaborator
• Sectra Benelux: collaborator
• iCAD: collaborator
• Dutch Foundation of Population Screening: collaborator

Study Sites (1)

Bevolkingsonderzoek Nederland

Utrecht, Netherlands

Location

Related Links

• STREAM website

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mireille Broeders, Prof.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Ioannis Sechopoulos, Prof.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Nicolien van Ravesteyn, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: September 28, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: For the duration of the study

Locations

NL (1)