Malmö Breast Tomosynthesis Screening Trial (MBTST)

Region Skane

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: DBT and FFDM

Study type: Interventional

Funder types: Other

Identifiers

NCT01091545

Dnr 2009/770

Details and patient eligibility

About

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

Full 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.

Enrollment: 15,000 patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15,000 participants in 1 patient group

FFDM+DBT

Other group

Description:

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

Treatment:

Radiation: DBT and FFDM