Malmö Breast Tomosynthesis Screening Trial

Breast Cancer Clinical Trial

— MBTST  

Official title:

Malmö Breast Tomosynthesis Screening Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091545
• Other study ID #: Dnr 2009/770
• Status: Completed
• Phase: N/A
• Start date: February 1, 2010
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: September 30, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• DBT 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.

Locations

Country	Name	City	State
Sweden	Malmö Breast Screening Unit, Skåne University Hospital	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Unilabs AB Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cost-effectiveness of DBT in screening	to investigate the cost-effectiveness of DBT in screening	24 months after trial screening