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Malmö Breast Tomosynthesis Screening Trial (MBTST)

R

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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