Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions

Completed

Conditions studied: Breast Neoplasms

In brief

The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.

Key facts

Study ID

NCT01773850

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

54

Starts

2013-01-01

Expected to finish

2018-01-01

Last updated by the study team

2018-03-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women at least 18 years old.
• Scheduled for breast biopsy of at least one breast lesion.
• Lesion detected on mammogram.
• Symptomatic by patient self-report, patient self-breast exam or clinical exam.
• Able to provide informed consent.

You may not qualify if…

• Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents <1% of newly diagnosed breast cancer)
• Less than 18 years of age.
• Patient unable to give consent.
• Institutionalized subject (prisoner or nursing home patient).
• Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating

Where it is running

• The University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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