Malmö Breast Tomosynthesis Screening Trial (MBTST)
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|ClinicalTrials.gov Identifier: NCT01091545|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2010
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: DBT and FFDM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01091545
|Malmö Breast Screening Unit, Skåne University Hospital|
|Malmö, Sweden, SE 20502|
|Principal Investigator:||Sophia Zackrisson, MD PhD||Region Skane|
|Principal Investigator:||Ingvar Andersson, MD PhD||Lund University|