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 : Active, not recruiting
First Posted : March 24, 2010
Last Update Posted : October 19, 2017
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15000 participants
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
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. Number of breast cancers detected by DBT [ Time Frame: 24 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
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

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

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

Responsible Party: Region Skane Identifier: NCT01091545     History of Changes
Other Study ID Numbers: Dnr 2009/770
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Region Skane:
breast cancer