Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Digital Breast Tomosynthesis, Digital Mammography, Breast cancer detection
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 25 Years
Gender: Female
Criteria: 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
Locations
Medical University of Graz
Graz, Styria, Austria
Status: Recruiting
Contact: Sabine Oswald, MD - +43 316385 - sabine.oswald@klinikum-graz.at
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Status: Recruiting
Contact: Stefan Meindl, MD - +437242415 - stefan.meindl@klinikum-wegr.at
Hanusch Krankenhaus
Vienna, Austria
Status: Recruiting
Contact: Reinhard Bernt, MD - +43191021 - reinhard.bernt@wgkk.at
Kaiser Franz Josef Spital
Vienna, Austria
Status: Recruiting
Contact: Gabrielle Kienzer, MD - +43160191 - Gabrielle.kienzer@wienkav.at
Medical University of Vienna
Vienna, Austria
Status: Recruiting
Contact: Thomas Moritz, MD - +43140400 - thomas.moritz@meduniwien.ac.at
Start Date
January 2012
Completion Date
December 2012
Sponsors
Medical University of Vienna
Source
Medical University of Vienna
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page