Detection of Breast Lesions by Automatic Breast US

March 20, 2017 updated by: Michal Guindy, Assuta Medical Center

Detection of Breast Lesions by Automatic Breast US (Comparison to Current Hand Held US and Pathological Findings When Exist).

Mammography is considered the standard imaging method for breast cancer screening, and is known to result in reduced mortality from breast cancer. However, the diagnostic yield of mammography depends particularly on breast tissue density, with sensitivity as low as 30-48% in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition of hand-held ultrasound to mammography has been demonstrated to significantly increase breast cancer detection in women with dense breasts. It is however dependent on the expertise and skill of the operator.

In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is relatively simple to use, necessitating less technical training, and results in higher reproducibility.

The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the detection and classification of breast lesions, compared to hand-held ultrasound, according to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS) classification. The investigator will also evaluate parameters regarding patients' comfort, workflow, and duration of image interpretation.

Study Overview

Status

Unknown

Conditions

Detailed Description

ABUS produces a 3D volume acquisition using a 6-15 Mega Herz reverse curve transducer. Images are digitally reformatted on a dedicated workstation to produce axial, sagittal and coronal reformatted images. Unlike handheld ultrasound, the ABUS is relatively simple to use, necessitating less technical training, and results in higher reproducibility. Previous studies have shown that automated breast ultrasound is very well tolerated by patients can be useful in detection of solid and cystic lesions and in evaluating tumor extent preoperatively.

Automated breast ultrasound will be performed on the "Invenia ABUS" (Automated Breast Ultrasound System) designed for automated breast imaging by General Electric (GE) Healthcare. Images will be acquired using a 15 centimeter field-of-view reverse curve ultra-broadband transducer of 6-15 Mega Herz. Using mechanical compression assist, the transducer is placed on each breast and six volumes are acquired with six sweeps (right anterior-posterior, right lateral, right medial; left anterior-posterior, left lateral, left medial). Acquisition time expected 15 minutes per patient, approximately 30-40 second acquisition per volume.

ABUS examinations will be performed by the investigators institution's radiographers, with variable degrees of experience in performing hand-held breast ultrasound examinations (HHUS).

Reformatted images and volumes will be view on a designated workstation of 2 megapixel high resolution monitor, using customized hanging protocols, multi-slice 3D viewing and patented clinical algorithms. Interpretation of images will be done by our institution's breast imaging radiologists with more than 15 years of experience in performing and reading hand-held breast ultrasound studies.

Each breast will be assigned a final ABUS BI-RADS score according to the American College of Radiology classification ranging from 1 to 6. A discrepancy between the ABUS Breast Imaging-Reporting and Data System score and the hand-held ultrasound BI-RADS score (HHUS BI-RADS 1-2 & ABUS BI-RADS >2, or HHUS BI-RADS >3 & ABUS BI-RADS 1-2) will result in the referral of the woman to second-look hand-held ultrasound to determine the reason for the mismatch.

Study Type

Observational

Enrollment (Anticipated)

1200

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

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Assuta Medical Centers
        • Contact:

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

25 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women 25 years and up reffered to our centers for hend held us for various indications including screening and diagnostic setup

Description

Inclusion Criteria:

Women referred to hand-held screening ultrasound examination (BI-RADS=1/2). Women scheduled to undergo ultrasound-guided needle biopsy due to suspicious breast mass detected during hand-held ultrasound (BI-RADS>2).

Exclusion Criteria:

Women under 25 years.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ability to identify all US breast findings correctly.
Time Frame: 6 month
The investigators will compare all lesions detected by abus and hand held US to pathology when present .
6 month

Collaborators and Investigators

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

Sponsor

Assuta Medical Center

Investigators

  • Principal Investigator: Yuliana Weinstein, MD, Assuta Medical Centers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2017

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (ESTIMATE)

February 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0089-16ASMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. U.S. Food and Drug Administration. somo-v Automated Breast Ultrasound System
    Information identifier: P110006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Ultrasonography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe