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Ultrasound Elastography of Breast Lesions (BE1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00716482
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Breast Neoplasms

Study Design

Study Type : Observational
Actual Enrollment : 1681 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions
Study Start Date : July 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716482


Locations
United States, California
University of Southern California - LAC+USC Medical Center, OPD Rm 3P61
Los Angeles, California, United States, 90033
United States, Colorado
Sally Jobe Breast Center
Denver, Colorado, United States, 80206
United States, Connecticut
Yale Medical Center, Department of Diagnostic Radiology
New Haven, Connecticut, United States, 06510
United States, Illinois
Northwestern Memorial Hospital, Dept. of Radiology
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston Medical Center, Radiology
Boston, Massachusetts, United States, 02118
United States, Pennsylvania
Thomas Jefferson Medical Center, Department of Radiology
Philadelphia, Pennsylvania, United States, 19107
France
Hôpital Privé Jean Mermoz
Lyon, France
University Hospital La Timone
Marseille, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Germany
University Hospital, Frauenklinik
Greifswald, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
Marienhospital, Klinik für Radiologie
Osnabrück, Germany
German Diagnostic Clinic
Wiesbaden, Germany
Italy
Ospedale Civile di Gorizia
Gorizia, Italy
United Kingdom
Charings Cross Hospital
London, United Kingdom
Sponsors and Collaborators
SuperSonic Imagine
Investigators
Principal Investigator: David O Cosgrove, MD Hammersmith Hospitals NHS Trust