Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Thomas Moritz, MD; Phone Number: 4818 +43140400; Email: thomas.moritz@meduniwien.ac.at
  • Vienna, Austria, A-1100
    • Recruiting
    • Kaiser Franz Josef Spital
    • Contact: Gabrielle Kienzer, MD; Phone Number: 3608 +43160191; Email: Gabrielle.kienzer@wienkav.at
  • Vienna, Austria, A-1140
    • Recruiting
    • Hanusch Krankenhaus
    • Contact: Reinhard Bernt, MD; Phone Number: 86630 +43191021; Email: reinhard.bernt@wgkk.at
  • Styria
    • Graz, Styria, Austria, A-8036
      • Recruiting
      • Medical University of Graz
      • Contact: Sabine Oswald, MD; Phone Number: 13850 +43 316385; Email: sabine.oswald@klinikum-graz.at
  • Upper Austria
    • Wels, Upper Austria, Austria, A-4600
      • Recruiting
      • Klinikum Wels-Grieskirchen
      • Contact: Stefan Meindl, MD; Phone Number: 2413 +437242415; Email: stefan.meindl@klinikum-wegr.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions	One year

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: January 29, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 1, 2012
• Last Update Submitted That Met QC Criteria: January 31, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Breast cancer detection; Digital Mammography; Digital Breast Tomosynthesis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TomoTrial001