Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Thomas Moritz, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01524029
First received: January 29, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders 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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524029

Contacts
Contact: Thomas Moritz, MD +43140400 ext 4818 thomas.moritz@meduniwien.ac.at
Contact: Thomas Helbich, Prof. MBA MSc +43140400 ext 4818 thomas.helbich@meduniwien.ac.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Styria, Austria, A-8036
Contact: Sabine Oswald, MD    +43 316385 ext 13850    sabine.oswald@klinikum-graz.at   
Klinikum Wels-Grieskirchen Recruiting
Wels, Upper Austria, Austria, A-4600
Contact: Stefan Meindl, MD    +437242415 ext 2413    stefan.meindl@klinikum-wegr.at   
Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Thomas Moritz, MD    +43140400 ext 4818    thomas.moritz@meduniwien.ac.at   
Hanusch Krankenhaus Recruiting
Vienna, Austria, A-1140
Contact: Reinhard Bernt, MD    +43191021 ext 86630    reinhard.bernt@wgkk.at   
Kaiser Franz Josef Spital Recruiting
Vienna, Austria, A-1100
Contact: Gabrielle Kienzer, MD    +43160191 ext 3608    Gabrielle.kienzer@wienkav.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Thomas Moritz, MD Medical University of Vienna
Study Director: Thomas Helbich, MD Prof. MBA MSc Medical University of Vienna
  More Information

No publications provided

Responsible Party: Thomas Moritz, Assistenzarzt, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01524029     History of Changes
Other Study ID Numbers: TomoTrial001
Study First Received: January 29, 2012
Last Updated: January 31, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on April 17, 2014