Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
Location
The University of North Carolina
Chapel Hill, North Carolina, United States
Status: Recruiting
Start Date
January 2013
Completion Date
January 2016
Sponsors
UNC Lineberger Comprehensive Cancer Center
Source
UNC Lineberger Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page