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Completed

NCT Number: NCT01091545

Malmö Breast Tomosynthesis Screening Trial

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hypersensitivity Immune System Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Malmö Breast Screening Unit, Skåne University Hospital

Malmö, SE 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

DBT and FFDM

Radiation

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Unilabs AB Sweden

Registry information

Acronym: MBTST

Important dates

Study start
2010
Primary completion
2017
Study completion
2019
First posted
Mar 24, 2010
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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