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.|
|ClinicalTrials.gov 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
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|
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|
|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|
Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
- Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions [ Time Frame: One year ]
- Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions [ Time Frame: One year ]
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 ClinicalTrials.gov identifier (NCT number): NCT01524029
|Contact: Thomas Moritz, MD||+43140400 ext email@example.com|
|Contact: Thomas Helbich, Prof. MBA MSc||+43140400 ext firstname.lastname@example.org|
|Medical University of Graz||Recruiting|
|Graz, Styria, Austria, A-8036|
|Contact: Sabine Oswald, MD +43 316385 ext 13850 email@example.com|
|Wels, Upper Austria, Austria, A-4600|
|Contact: Stefan Meindl, MD +437242415 ext 2413 firstname.lastname@example.org|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, A-1090|
|Contact: Thomas Moritz, MD +43140400 ext 4818 email@example.com|
|Kaiser Franz Josef Spital||Recruiting|
|Vienna, Austria, A-1100|
|Contact: Gabrielle Kienzer, MD +43160191 ext 3608 Gabrielle.firstname.lastname@example.org|
|Vienna, Austria, A-1140|
|Contact: Reinhard Bernt, MD +43191021 ext 86630 email@example.com|
|Principal Investigator:||Thomas Moritz, MD||Medical University of Vienna|
|Study Director:||Thomas Helbich, MD Prof. MBA MSc||Medical University of Vienna|