Digital Breast Tomosynthesis Preference Study
Mammography remains the current standard in the detection of breast cancer. However, conventional two-view mammography will not detect all cancers. The major limiting factor of conventional mammography is the presence of superimposed breast tissue that can obscure clinically significant lesions. It is this limitation that decreases the sensitivity of mammography and leads to false negative results.
The recent development of digital detectors has allowed imaging technologies such as tomosynthesis to become clinically feasible. The examination, similar to conventional mammography with regard to patient positioning and glandular dose, allows acquisition of a digital data set that can be reconstructed and viewed in multiple sections. The ability of tomosynthesis to unmask overlapping structures has been shown in preliminary studies to increase lesion visibility. Used as either a primary imaging modality, or as an adjunct to screening mammography, tomosynthesis has the potential to provide increased sensitivity and a lower number of false negative examinations.
The purpose of this study is to compare radiologist impression of digital breast tomosynthesis to digital mammography with respect to their ability to see and characterize specific lesion features.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Radiologists' Preference Study - Digital Breast Tomosynthesis|
- Reader Preference [ Time Frame: upon recruitment/enrollment phase completion ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
All enrolled subjects will undergo digital breast tomosynthesis.
Device: Digital Breast Tomosynthesis Exam
Digital Breast Tomosynthesis Exam consisting of single view (MLO) of each breast will be performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776126
|United States, North Carolina|
|Breast Imaging Clinic; University of North Carolina Hospitals|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Amy S Campbell, MD||University of South Carolina|
|Principal Investigator:||Etta D Pisano, MD||University of North Carolina, Chapel Hill|