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

Breast Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02997540
• Other study ID #: BVN G-1000
• Status: Terminated
• Start date: November 2016
• Est. completion date: January 2020

Study information

• Verified date: July 2021
• Source: MetriTrack, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases

Locations

Country	Name	City	State
United States	Evanston Hospital	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
MetriTrack, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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