Malmö Breast Tomosynthesis Screening Trial
Phase: NA
Conditions: Breast Cancer
Sponsor: Region Skane

Study protocol 
Version 1, 2009-11-30 
Malmö Breast Tomosynthesis Screening Trial, MBTST 
 
Principal investigator 
Sophia Zackrisson MD, PhD 
Department of Translational Medicine, Diagnostic Radiology 
Lund University and Skåne University Hospital Malmö 
sophia.zackrisson@med.lu.se 
 
 
Synopsis 
Study title 
Malmö Breast Tomosynthesis Screening Trial, MBTST 
http://www.clinicaltrials.gov/; NCT01091545 
Study phase 
N/A 
Background 
Digital breast tomosynthesis, DBT (or 3D mammography) is a development 
of the currently used method in breast cancer screening, digital 
mammography, DM, that may increase the visibility of breast cancers and 
hence the detection.  
 
 
Study setting 
Within the population based screening programme in Malmö, Sweden. 
Skåne University Hospital Malmö, Unilabs Breast Centre. 
 
 
Study design 
Prospective, paired, one-armed study in a population-based screening 
program 
 
 
Objectives 
Primary objective:  
• 
to investigate the sensitivity and specificity of breast cancer 
detection with DBT compared to DM. 
 Secondary objectives: 
- to investigate the biological characteristics of the cancers in the trial by 
 
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mode of detection 
- to investigate the cost-effectiveness of DBT in screening 
 
 
 
Study 
population 
Inclusion criteria: a random selection of women aged 40-74 years invited to 
participate in mammography screening in Malmö 
Exclusion criteria: Pregnancy and/or women not understanding Swedish or 
English  
 
 
Methods 
Women will undergo both DBT in the medio-lateral oblique (MLO) 
projection and DM in MLO as well as cranio-caudal projection (CC). Reading 
of DBT and DM will be done independently. In addition, the DBT 
examination will be read together with the DM CC-view in order to assess 
the separate contribution of the DM CC-view. All studies will be double 
read.  
A two-year follow up and matching to the cancer registry will be performed 
to ascertain screening detected cancers and interval cancers.  
 
 
Assessments 
Women who are recalled for further assessment based on any method will 
be investigated according to so called triple assessment. 
 
 
Statistical 
considerations 
About 15,000 women are needed for this study in order to yield an 80% 
chance of getting a statistically significant outcome, i.e. detecting an 
increase in TPF and confirming that the FPF is within the acceptable limit of 
20%. 
 
 
Potential 
benefit: 
An improved breast cancer detection with DBT may increase the benefits of 
breast cancer screening and further contribute to reduced mortality in 
breast cancer.  
 
 
 
 
 
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