Malmö Breast Tomosynthesis Screening Trial

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: DBT and FFDM

• Registration Number: NCT01091545
• Lead Sponsor: Region Skane

Brief Summary

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

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 Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2017-12-31
• Study Completion: 2019-09-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FFDM+DBT	DBT and FFDM	Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity for breast cancer detection for DBT and DM respectively	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

Name	Time	Method
Cost-effectiveness of DBT in screening	24 months after trial screening	to investigate the cost-effectiveness of DBT in screening
What kind of cancers are detected and not detected with DBT?	24 months after trial screening	To investigate the biological characteristics of the cancers in the trial by mode of detection (screening detected, interval cancers)

Trial Locations

Locations (1)

Malmö Breast Screening Unit, Skåne University Hospital; 🇸🇪 Malmö, Sweden