Ultrasound Elastography of Breast Lesions (BE1)

September 2, 2013 updated by: SuperSonic Imagine

Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1681

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

  • France
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Marseille, France
        • University hospital La Timone
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Institut Curie
  • Germany
      • Greifswald, Germany
        • University Hospital, Frauenklinik
      • Kiel, Germany
        • University Hospital Schleswig-Holstein
      • Osnabrück, Germany
        • Marienhospital, Klinik für Radiologie
      • Wiesbaden, Germany
        • German Diagnostic Clinic
  • Italy
      • Gorizia, Italy
        • Ospedale Civile di Gorizia
  • United Kingdom
      • London, United Kingdom
        • Charings Cross Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California - LAC+USC Medical Center, OPD Rm 3P61
    • Colorado
      • Denver, Colorado, United States, 80206
        • Sally Jobe Breast Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Medical Center, Department of Diagnostic Radiology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital, Dept. of Radiology
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center, Radiology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Medical Center, Department of Radiology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Population will consist of women who have been referred to a public or private hospital or clinic for a breast ultrasound evaluation. The sites are located various cities throughout the United States and Europe.

Description

Inclusion Criteria:

  • patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.
  • female
  • age 21 or older
  • provide informed consent

Exclusion Criteria:

  • Women who are unwilling or unable to provide informed consent
  • Women with breast implants
  • Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface)
  • Women who are pregnant or breastfeeding
  • Women who are undergoing chemotherapy or radiotherapy for any cancer
  • Women with previous breast conserving surgery on the breast of interest Note: Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
Time Frame: 2 years

Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.

Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.

Based on 939 lesions.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
Time Frame: performed on the same day, within 2 years from study start date
614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.
performed on the same day, within 2 years from study start date
Intraobserver Reliability of Quantitative SWE Measurements
Time Frame: performed on the same day, within 2 years from study start date
614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.
performed on the same day, within 2 years from study start date
Interobserver Agreement of B Mode Ultrasound and SWE Features
Time Frame: performed on the same day, after study completion
614 benign and 144 malignant breast masses.
performed on the same day, after study completion

Collaborators and Investigators

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

Sponsor

SuperSonic Imagine

Investigators

  • Principal Investigator: David O Cosgrove, MD, Hammersmith Hospitals NHS Trust

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

July 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00152-53

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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