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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02997540

Enrollment

Registered

2016-12-20

Start date

2016-11-30

Completion date

2020-01-31

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Diseases

Keywords

female breast lesion, ultrasound examination

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results