Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

NCT01524029 | Unknown

• 1 other identifier: TomoTrial001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Breast Neoplasms

Keywords

Digital Breast Tomosynthesis; Digital Mammography; Breast cancer detection

Outcome Measures

Primary Outcomes (1)

• Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions

  One year

Secondary Outcomes (1)

• Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions

  One year

Study Arms (2)

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

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Pregnant and breast feeding women
• Unable to tolerate breast compression
• Breast implants
• Unable to understand or execute written informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (5)

Medical University of Graz

Graz, Styria, A-8036, Austria

RECRUITING

Klinikum Wels-Grieskirchen

Wels, Upper Austria, A-4600, Austria

RECRUITING

Medical University of Vienna

Vienna, A-1090, Austria

RECRUITING

Kaiser Franz Josef Spital

Vienna, A-1100, Austria

RECRUITING

Hanusch Krankenhaus

Vienna, A-1140, Austria

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas Moritz, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Thomas Helbich, MD Prof. MBA MSc

  Medical University of Vienna

  STUDY DIRECTOR

Central Study Contacts

Thomas Moritz, MD

CONTACT

+43140400; thomas.moritz@meduniwien.ac.at

Thomas Helbich, Prof. MBA MSc

CONTACT

+43140400; thomas.helbich@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistenzarzt

Study Record Dates

• First Submitted: January 29, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

AU (5)