Digital Breast Tomosynthesis Preference Study (NRR)
|ClinicalTrials.gov Identifier: NCT00776126|
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : March 6, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Digital Breast Tomosynthesis Exam|
|Study Type :||Observational|
|Actual Enrollment :||51 participants|
|Official Title:||Radiologists' Preference Study - Digital Breast Tomosynthesis|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||June 2010|
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.
- Reader Preference [ Time Frame: upon recruitment/enrollment phase completion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|