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Malmö Breast Tomosynthesis Screening Trial (MBTST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091545
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : November 13, 2019
Unilabs AB Sweden
Information provided by (Responsible Party):
Region Skane

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

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: DBT and FFDM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Malmö Breast Tomosynthesis Screening Trial
Actual Study Start Date : February 1, 2010
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Sensitivity and specificity for breast cancer detection for DBT and DM respectively [ Time Frame: 24 months after trial screening ]
    Sensitivity and specificity for breast cancer detection will be assessed for DBT and DM respectively. The following screening performance measures will also also investigated: the number of detected cancers per 1000 women screened, the number of recalled women/100 screens (recall rate) after consensus, and the positive predictive value (PPV) for screen-recall and the negative predictive value (NPV), in both reading arms. Analyses of the contribution from different reading steps will be investigated. 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.

Secondary Outcome Measures :
  1. What kind of cancers are detected and not detected with DBT? [ Time Frame: 24 months after trial screening ]
    To investigate the biological characteristics of the cancers in the trial by mode of detection (screening detected, interval cancers)

  2. Cost-effectiveness of DBT in screening [ Time Frame: 24 months after trial screening ]
    to investigate the cost-effectiveness of DBT in screening

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women 40-74 years old
  • in the regular population based mammographic screening program in Malmö, Sweden.

Exclusion Criteria: pregnancy and women not speaking English or Swedish


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091545

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Malmö Breast Screening Unit, Skåne University Hospital
Malmö, Sweden, SE 20502
Sponsors and Collaborators
Region Skane
Unilabs AB Sweden
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Principal Investigator: Sophia Zackrisson, MD PhD Region Skane
Principal Investigator: Ingvar Andersson, MD PhD Lund University
  Study Documents (Full-Text)

Documents provided by Region Skane:
Study Protocol  [PDF] October 30, 2009

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Region Skane Identifier: NCT01091545    
Other Study ID Numbers: Dnr 2009/770
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Keywords provided by Region Skane:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases