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

UNC Lineberger Comprehensive Cancer Center54 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Neoplasms

Interventions

Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis ScannerDEVICE

All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of North Carolina

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)

Receiver Operative Curve (ROC) Area Under the Curve (AUC) analysis of the stationary breast tomosynthesis (SDBT) system for the the characterization of suspicious breast lesions in comparison to x-ray mammography.

Time frame: approximately 18 months

Secondary Outcomes

Reader preference - arbitrary units

To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.

Time frame: approximately 18 months

Data from ClinicalTrials.gov

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