Malmö Breast Tomosynthesis Screening Trial

Conditions

Breast Cancer

Keywords

breast cancer, screening, sensitivity, tomosynthesis

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.

Jögi A, Johnson K, Wittgren S, Sundgren V, Tomic H, Olinder J, Åkesson A, Andersson I, Zackrisson S, Bakic PR.

2024-07-013 citations

10.1148/radiol.233417

Impact of breast density on diagnostic accuracy in digital breast tomosynthesis versus digital mammography: results from a European screening trial

Jakob Olinder, Kristin Johnson, Anna Åkesson, Daniel Förnvik, Sophia Zackrisson

Breast Cancer Research2023-10-0412 citations

10.1186/s13058-023-01712-6

Artificial Intelligence Detection of Missed Cancers at Digital Mammography That Were Detected at Digital Breast Tomosynthesis

Victor Dahlblom, Ingvar Andersson, Kristina Lång, Anders Tingberg, Sophia Zackrisson et al. (6 authors)

Radiology Artificial Intelligence2021-09-0120 citations

10.1148/ryai.2021200299

One-view breast tomosynthesis versus two-view mammography in the Malmö Breast Tomosynthesis Screening Trial (MBTST): a prospective, population-based, diagnostic accuracy study.

Zackrisson S, Lång K, Rosso A, Johnson K, Dustler M, Förnvik D, Förnvik H, Sartor H, Timberg P, Tingberg A, Andersson I.

2018-10-12128 citations

10.1016/s1470-2045(18)30521-7

Interventions

RADIATIONDBT 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.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 74 Years

Healthy volunteers

No

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 \-

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
Cost-effectiveness of DBT in screening	24 months after trial screening	to investigate the cost-effectiveness of DBT in screening

Countries

Sweden

Outcome results

None listed