Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
NCT ID: NCT01524029
Last Updated: 2012-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
600 participants
OBSERVATIONAL
2012-01-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
NCT01106911
Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography
NCT03377036
Digital 3D Breast Tomosynthesis Versus 2D in Clinical Evaluation of High Risk Women
NCT02209129
Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
NCT00535184
Prospective Trial of Digital Breast Tomosynthesis (DBT) in Breast Cancer Screening.
NCT03733106
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
No interventions assigned to this group
Diagnostic Patients
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Unable to tolerate breast compression
* Breast implants
* Unable to understand or execute written informed consent
25 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Moritz
Assistenzarzt
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Moritz, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Thomas Helbich, MD Prof. MBA MSc
Role: STUDY_DIRECTOR
Medical University of Vienna
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Graz
Graz, Styria, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Medical University of Vienna
Vienna, , Austria
Kaiser Franz Josef Spital
Vienna, , Austria
Hanusch Krankenhaus
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TomoTrial001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.