This trial is active, not recruiting.

Condition breast cancer
Treatment dbt and ffdm
Sponsor Region Skane
Collaborator Unilabs AB Sweden
Start date March 2010
End date December 2017
Trial size 15000 participants
Trial identifier NCT01091545, Dnr 2009/770


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis.
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.

Primary Outcomes

Number of breast cancers detected by DBT
time frame: 24 months

Eligibility Criteria

Female participants from 40 years up to 74 years old.

Inclusion Criteria: - women 40-74 years old - in the regular population based mammographic screening program in Malmö, Sweden. Exclusion Criteria: pregnancy -

Additional Information

Official title Malmö Breast Tomosynthesis Screening Trial
Principal investigator Sophia Zackrisson, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Region Skane.