NCT01091545

Malmö Breast Tomosynthesis Screening Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15,000 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 40 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.

Detailed description

Mammography is the only approved method for breast cancer screening, but not all tumors can be detected with mammography. The main reason is overlapping structures that can either mimic or hide a tumor on a 2-dimensional image like mammography. Digital breast tomosynthesis, (DBT) is a 3-dimensional x-ray technique that has been developed during the last years. A tomographic technique like DBT, which reduces or eliminates the detrimental effect of over- and underlying tissue, can probably help to find more tumors. This study aims to investigate whether more breast cancers can be detected with DBT compared to full field digital mammography (FFDM) in population invited to screening. An interim analysis will be performed during 2013 including the first 7,500 women of the study cohort.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	DBT and FFDM	Women in the study will once undergo both standard FFDM screening (2-views) and DBT (1 view, MLO). This will result in a doubled radiation dose compared to only 2-view FFDM, which is the standard procedure for women in the screening program.

Timeline

• Start date: 2010-02-01
• Primary completion: 2017-12-31
• Completion: 2019-09-30
• First posted: 2010-03-24
• Last updated: 2019-11-13

Locations

1 site across 1 country: Sweden