Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524029
Recruitment Status : Unknown
Verified January 2012 by Thomas Moritz, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
Information provided by (Responsible Party):
Thomas Moritz, Medical University of Vienna

Brief Summary:

The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.

DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.

This is a study conducted in several Austrian Breast Imaging Centers.

Condition or disease
Breast Neoplasms

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
Study Start Date : January 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
Diagnostic Patients
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion

Primary Outcome Measures :
  1. Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population consists of two groups:

One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination.

The second group consists of women aged 25+ referred for further examination of a breast lesion.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524029

Contact: Thomas Moritz, MD +43140400 ext 4818
Contact: Thomas Helbich, Prof. MBA MSc +43140400 ext 4818

Medical University of Graz Recruiting
Graz, Styria, Austria, A-8036
Contact: Sabine Oswald, MD    +43 316385 ext 13850   
Klinikum Wels-Grieskirchen Recruiting
Wels, Upper Austria, Austria, A-4600
Contact: Stefan Meindl, MD    +437242415 ext 2413   
Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Thomas Moritz, MD    +43140400 ext 4818   
Kaiser Franz Josef Spital Recruiting
Vienna, Austria, A-1100
Contact: Gabrielle Kienzer, MD    +43160191 ext 3608   
Hanusch Krankenhaus Recruiting
Vienna, Austria, A-1140
Contact: Reinhard Bernt, MD    +43191021 ext 86630   
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Thomas Moritz, MD Medical University of Vienna
Study Director: Thomas Helbich, MD Prof. MBA MSc Medical University of Vienna

Responsible Party: Thomas Moritz, Assistenzarzt, Medical University of Vienna Identifier: NCT01524029     History of Changes
Other Study ID Numbers: TomoTrial001
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Thomas Moritz, Medical University of Vienna:
Digital Breast Tomosynthesis
Digital Mammography
Breast cancer detection

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases