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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 : June 11, 2018
Sponsor:
Collaborator:
Unilabs AB Sweden
Information provided by (Responsible Party):
Region Skane

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

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: DBT and FFDM Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Malmö Breast Tomosynthesis Screening Trial
Actual Study Start Date : February 1, 2010
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
FFDM+DBT
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes 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 and women not speaking English or Swedish


Information from the National Library of Medicine

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


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 PhD Lund University
  Study Documents (Full-Text)

Documents provided by Region Skane:
Study Protocol  [PDF] October 30, 2009


Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01091545     History of Changes
Other Study ID Numbers: Dnr 2009/770
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Keywords provided by Region Skane:
breast cancer
screening
sensitivity
tomosynthesis