Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Unilabs AB Sweden | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFDM+DBT | Other | Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBT and FFDM | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity for breast cancer detection for DBT and DM respectively | 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. | 24 months after trial screening |
| Measure | Description | Time Frame |
|---|---|---|
| What kind of cancers are detected and not detected with DBT? | To investigate the biological characteristics of the cancers in the trial by mode of detection (screening detected, interval cancers) | 24 months after trial screening |
| Cost-effectiveness of DBT in screening |
Not provided
Inclusion Criteria:
Exclusion Criteria: pregnancy and women not speaking English or Swedish
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sophia Zackrisson, MD PhD | Region Skane | Principal Investigator |
| Ingvar Andersson, MD PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malmö Breast Screening Unit, Skåne University Hospital | Malmö | SE 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37794480 | Derived | Olinder 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. | |
| 34870215 | Derived | 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. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2009 | May 14, 2018 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
to investigate the cost-effectiveness of DBT in screening |
| 24 months after trial screening |
| 30322817 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |