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

Completed

• Conditions: Breast Neoplasms
• Interventions: Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner

• Registration Number: NCT01773850
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Status Verified: 2017-04
• Primary Completion: 2017-10
• Study Completion: 2018-01
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner	Patients with a breast lesion undergoing surgical biopsy. All patients will undergo stationary Carbon Nanotube x-ray digital breast tomosynthesis imaging in addition to routine conventional digital mammography.

Primary Outcome Measures

Name	Time	Method
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)	approximately 18 months	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.

Secondary Outcome Measures

Name	Time	Method
Reader preference - arbitrary units	approximately 18 months	To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.

Trial Locations

Locations (1)

The University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States