Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

Trial Title: Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

NCT ID: NCT01524029

Condition: Breast Neoplasms

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Digital Breast Tomosynthesis
Digital Mammography
Breast cancer detection

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

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.

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: Female

Minimum age: 25 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Medical University of Graz

Address:
City: Graz
Zip: A-8036
Country: Austria

Status: Recruiting

Contact:
Last name: Sabine Oswald, MD

Phone: +43 316385

Phone ext: 13850
Email: sabine.oswald@klinikum-graz.at

Facility:
Name: Klinikum Wels-Grieskirchen

Address:
City: Wels
Zip: A-4600
Country: Austria

Status: Recruiting

Contact:
Last name: Stefan Meindl, MD

Phone: +437242415

Phone ext: 2413
Email: stefan.meindl@klinikum-wegr.at

Facility:
Name: Medical University of Vienna

Address:
City: Vienna
Zip: A-1090
Country: Austria

Status: Recruiting

Contact:
Last name: Thomas Moritz, MD

Phone: +43140400

Phone ext: 4818
Email: thomas.moritz@meduniwien.ac.at

Facility:
Name: Kaiser Franz Josef Spital

Address:
City: Vienna
Zip: A-1100
Country: Austria

Status: Recruiting

Contact:
Last name: Gabrielle Kienzer, MD

Phone: +43160191

Phone ext: 3608
Email: Gabrielle.kienzer@wienkav.at

Facility:
Name: Hanusch Krankenhaus

Address:
City: Vienna
Zip: A-1140
Country: Austria

Status: Recruiting

Contact:
Last name: Reinhard Bernt, MD

Phone: +43191021

Phone ext: 86630
Email: reinhard.bernt@wgkk.at

Start date: January 2012

Completion date: December 2012

Lead sponsor:
Agency: Medical University of Vienna
Agency class: Other

Source: Medical University of Vienna

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01524029