CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Digital Breast Tomosynthesis Examdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00776126
NCT00776126N/ACompleted

Radiologists' Preference Study - Digital Breast Tomosynthesis

UNC Lineberger Comprehensive Cancer Center·observational·Posted Oct 20, 2008·Updated Mar 6, 2017

In Brief

An observational study evaluating Digital Breast Tomosynthesis Exam for Breast Cancer. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGE Healthcare

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2008
Enrollment StartOct 1, 2008
Primary CompletionApr 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.7 years ago

Interventions

Digital Breast Tomosynthesis Examdevice

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