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

MetriTrack, Inc.20 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Diseases

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female 2. 21-70 years of age 3. 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: 1. Women with cardiac pacemaker or portable defibrillator 2. Women with known breast cancer or suspicious lesions 3. Pregnant and lactating women 4. Women who have breast implant(s) 5. Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass. 6. Women with the target finding to be mapped within a distance of 4 cm from patient's nipple. 7. Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets). 8. Women with history of allergy to medical-grade adhesive tape or ultrasound gel 9. Women whose weight is over 250 pounds

Locations (1)

Evanston Hospital

Evanston, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: study completion, an average of 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.