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

July 15, 2021 updated by: MetriTrack, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females of any ethnic group who meet all inclusion and none of the exclusion criteria will be eligible for enrollment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
female breast ultrasound exam
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
movement of a given ultrasound breast lesion
Time Frame: 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
study completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetriTrack, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVN G-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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