Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524029
• Other study ID #: TomoTrial001
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2012
• Last updated: January 31, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: Medical University of Vienna
• Contact: Thomas Moritz, MD
• Phone: +43140400
• Email: thomas.moritz[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria
Austria	Hanusch Krankenhaus	Vienna
Austria	Kaiser Franz Josef Spital	Vienna
Austria	Medical University of Vienna	Vienna
Austria	Klinikum Wels-Grieskirchen	Wels	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions		One year	No
Secondary	Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions		One year	No