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.|
|ClinicalTrials.gov Identifier: NCT01091545|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : November 13, 2019
|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|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||September 30, 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.
- 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.
- 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)
- Cost-effectiveness of DBT in screening [ Time Frame: 24 months after trial screening ]to investigate the cost-effectiveness of DBT in screening
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|