Clinical trial NCT01524029: Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Official title: Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Digital Breast Tomosynthesis
Digital Mammography
Breast cancer detection
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 600
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
timeFrame: One year
Secondary outcomes:
measure: Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
timeFrame: One year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Upper Austria
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Kaiser Franz Josef Spital
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
Study officials:
affiliation: Medical University of Vienna
name: Thomas Moritz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Thomas Helbich, MD Prof. MBA MSc
role: STUDY_DIRECTOR
References: