Clinical trial NCT01091545: Malmö Breast Tomosynthesis Screening Trial
Official title: Malmö Breast Tomosynthesis Screening Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
screening
sensitivity
tomosynthesis
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Unilabs AB Sweden
First posted: 2010-03-24
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

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Primary outcomes:
measure: Sensitivity and specificity for breast cancer detection for DBT and DM respectively
timeFrame: 24 months after trial screening
Secondary outcomes:
measure: What kind of cancers are detected and not detected with DBT?
timeFrame: 24 months after trial screening
measure: Cost-effectiveness of DBT in screening
timeFrame: 24 months after trial screening
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Breast Screening Unit, Skåne University Hospital
Study officials:
affiliation: Region Skane
name: Sophia Zackrisson, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Ingvar Andersson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dahlblom V, Andersson I, Lang K, Tingberg A, Zackrisson S, Dustler M. Artificial Intelligence Detection of Missed Cancers at Digital Mammography That Were Detected at Digital Breast Tomosynthesis. Radiol Artif Intell. 2021 Sep 1;3(6):e200299. doi: 10.1148/ryai.2021200299. eCollection 2021 Nov.
citation: Zackrisson S, Lang K, Rosso A, Johnson K, Dustler M, Fornvik D, Fornvik H, Sartor H, Timberg P, Tingberg A, Andersson I. One-view breast tomosynthesis versus two-view mammography in the Malmo Breast Tomosynthesis Screening Trial (MBTST): a prospective, population-based, diagnostic accuracy study. Lancet Oncol. 2018 Nov;19(11):1493-1503. doi: 10.1016/S1470-2045(18)30521-7. Epub 2018 Oct 12.