Malmö Breast Tomosynthesis Screening Trial (MBTST)
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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 |
- 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: | December 2014 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
-
Radiation: DBT and FFDM
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.
Eligibility| Ages Eligible for Study: | 40 Years to 74 Years |
| Genders 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
-
Contacts and Locations| Sweden | |
| Malmö Breast Screening Unit, Skåne University Hospital | |
| Malmö, Sweden, SE 20502 | |
| 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: | September 30, 2011 |
| 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 May 16, 2013