Clinical Trials Directory

Trials / Completed

CompletedNCT00776126

Digital Breast Tomosynthesis Preference Study

Radiologists' Preference Study - Digital Breast Tomosynthesis

Status
Completed
Phase
Study type
Observational
Enrollment
51 (actual)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEDigital Breast Tomosynthesis ExamDigital Breast Tomosynthesis Exam consisting of single view (MLO) of each breast will be performed.

Timeline

Start date
2008-10-01
Primary completion
2010-04-01
Completion
2010-06-01
First posted
2008-10-20
Last updated
2017-03-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00776126. Inclusion in this directory is not an endorsement.