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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>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. | Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner<br>* All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.<br>* Other names: Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | approximately 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer