Malmö Breast Tomosynthesis Screening Trial (MBTST)
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Malmö Breast Tomosynthesis Screening Trial|
- Number of breast cancers detected by DBT [ Time Frame: 24 months ] [ Designated as safety issue: No ]The number of breast cancers detected by DBT will be compared with the number detected by DM. A follow-up period of 24 months after the intervention period will provide information on the actual numbers of breast cancers in the study population through record linkage with the Swedish Cancer Registry. Sensitivity and specificity for breast cancer detection will be assessed for DBT and BT respectively.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091545
|Malmö Breast Screening Unit, Skåne University Hospital|
|Malmö, Sweden, SE 20502|
|Principal Investigator:||Sophia Zackrisson, MD PhD||Region Skane|
|Principal Investigator:||Ingvar Andersson, MD PhD||Lund University|