NCT01091545

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

7.9 years

First QC Date

March 12, 2010

Last Update Submit

November 11, 2019

Conditions

Breast Cancer

Keywords

breast cancerscreeningsensitivitytomosynthesis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • What kind of cancers are detected and not detected with DBT?

    24 months after trial screening

  • Cost-effectiveness of DBT in screening

    24 months after trial screening

Study Arms (1)

FFDM+DBT

OTHER

Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis.

Radiation: DBT and FFDM

Interventions

DBT and FFDMRADIATION

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.

FFDM+DBT

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women 40-74 years old
  • in the regular population based mammographic screening program in Malmö, Sweden.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malmö Breast Screening Unit, Skåne University Hospital

Malmo, SE 20502, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 37794480DERIVED

  • 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.

    PMID: 34870215DERIVED

  • 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.

    PMID: 30322817DERIVED

MeSH Terms

Conditions

Breast NeoplasmsHypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Study Officials

  • Sophia Zackrisson, MD PhD

    Region Skane

    PRINCIPAL INVESTIGATOR

  • Ingvar Andersson, MD PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 24, 2010

Study Start

February 1, 2010

Primary Completion

December 31, 2017

Study Completion

September 30, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

SE(1)