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Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial

25 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial

This prospective national multicenter multivendor trial aims at determining the impact of
the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for
breast cancer. Mammography is the primary imaging modality for the early detection of
clinically occult breast cancer.

Despite advances in mammographic technique, mammography is still limited with regard to both
sensitivity and specificity. In the majority of cases these limitations arise from the
masking of subtle breast cancer lesions by overlapping breast tissue.

DBT is a novel technique that tries to overcome these limitations by performing a
3D-reconstruction of breast tissue from multiple low-dose digital mammographic images
acquired in several planes in a 15 to 50 degree angle.

Early studies indicate an advantage of DBT compared to the standard Full Field Digital
Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.

Controversy continues over the use of DBT in combination with FFDM or as a standalone
screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed
publications evaluating DBT are limited and consist of single institution studies with a
small number of participants.

The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM
in a clinical large sample study (600 participants) to provide the path to implementation of
this new technique into clinical and screening routine.

Inclusion Criteria:

- Age > 25 years (40 years or older for Screening Cohort)

- No history of breast cancer

- Written informed consent

- Asymptomatic women in follow up for early detection of breast cancer or

- Patients with a recent positive mammography (BI-RADS 3-5)

Exclusion Criteria:

- Pregnant and breast feeding women

- Unable to tolerate breast compression

- Breast implants

- Unable to understand or execute written informed consent

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Thomas Moritz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna


Austria: Federal Office for Safety in Health Care

Study ID:




Start Date:

January 2012

Completion Date:

December 2012

Related Keywords:

  • Breast Neoplasms
  • Digital Breast Tomosynthesis
  • Digital Mammography
  • Breast cancer detection
  • Breast Neoplasms
  • Neoplasms