Effect of Body Position and Probe Position on the Localization of Breast Mass

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.

Detailed Description
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The proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. Measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. The manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.

Official Title
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Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination

Conditions
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Breast Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 21-70 years of age Known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination Exclusion Criteria: Women with cardiac pacemaker or portable defibrillator Women with known breast cancer or suspicious lesions Pregnant and lactating women Women who have breast implant(s) Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass. Women with the target finding to be mapped within a distance of 4 cm from patient's nipple. Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets). Women with history of allergy to medical-grade adhesive tape or ultrasound gel Women whose weight is over 250 pounds

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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 |
| --- | --- |
| female breast ultrasound exam<br>females with at least one benign or probably benign mass, up to 2 cm in size, in one breast, detected during a standard-of-care breast ultrasound examination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| movement of a given ultrasound breast lesion | movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations | study completion, an average of 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female breast lesion, ultrasound examination