Clinical trial · Interventional
Malmö Breast Tomosynthesis Screening Trial
NCT01091545CI-TRIAL-00041592MBTSTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DBT and FFDM | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FFDM+DBT
- description
- Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis.
- interventionNames
- Radiation: DBT and FFDM
Primary outcomes (1)
- measure
- Sensitivity and specificity for breast cancer detection for DBT and DM respectively
- timeFrame
- 24 months after trial screening
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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 \-
References
Publications (3)
- DERIVEDOlinder J, Johnson K, Akesson A, Fornvik D, Zackrisson S. Impact of breast density on diagnostic accuracy in digital breast tomosynthesis versus digital mammography: results from a European screening trial. Breast Cancer Res. 2023 Oct 4;25(1):116. doi: 10.1186/s13058-023-01712-6. PMID 37794480
- DERIVEDDahlblom 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. PMID 34870215
- DERIVEDZackrisson 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. PMID 30322817