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Digital Breast Tomosynthesis Preference Study

NCT00776126 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2017-03-06

No results posted yet for this study

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

DEVICE

Digital Breast Tomosynthesis Exam

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

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Amy S Campbell, MD · University of South Carolina

  • Etta D Pisano, MD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00776126 on ClinicalTrials.gov