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Malmö Breast Tomosynthesis Screening Trial

40 Years
74 Years
Open (Enrolling by invite only)
Breast Cancer

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Trial Information

Malmö Breast Tomosynthesis Screening Trial

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.

Inclusion Criteria:

- women 40-74 years old

- in the regular population based mammographic screening program in Malmö, Sweden.

Exclusion Criteria: pregnancy


Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of breast cancers detected by DBT

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Sophia Zackrisson, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Region Skane


Sweden: Regional Ethical Review Board

Study ID:

Dnr 2009/770



Start Date:

March 2010

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • breast cancer
  • screening
  • sensitivity
  • tomosynthesis
  • Breast Neoplasms