Malmö Breast Tomosynthesis Screening Trial (MBTST)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Unilabs AB Sweden
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01091545
First received: March 12, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Breast Cancer
Radiation: DBT and FFDM

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Malmö Breast Tomosynthesis Screening Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 15000
Study Start Date: March 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria: pregnancy

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091545

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

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01091545     History of Changes
Other Study ID Numbers: Dnr 2009/770
Study First Received: March 12, 2010
Last Updated: July 5, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
breast cancer
screening
sensitivity
tomosynthesis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014