Ultrasound Elastography of Breast Lesions (BE1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SuperSonic Imagine
ClinicalTrials.gov Identifier:
NCT00716482
First received: July 14, 2008
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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
Breast Neoplasms

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by SuperSonic Imagine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature [ Time Frame: performed on the same day, within 2 years from study start date ] [ Designated as safety issue: No ]
    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.

  • Intraobserver Reliability of Quantitative SWE Measurements [ Time Frame: performed on the same day, within 2 years from study start date ] [ Designated as safety issue: No ]
    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.

  • Interobserver Agreement of B Mode Ultrasound and SWE Features [ Time Frame: performed on the same day, after study completion ] [ Designated as safety issue: No ]
    614 benign and 144 malignant breast masses.


Enrollment: 1681
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital, London, UK
  More Information

Publications:
Responsible Party: SuperSonic Imagine
ClinicalTrials.gov Identifier: NCT00716482     History of Changes
Other Study ID Numbers: A00152-53
Study First Received: July 14, 2008
Results First Received: April 4, 2013
Last Updated: September 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
United Kingdom: National Health Service
United States: Institutional Review Board
Germany: German Institute of Medical Documentation and Information

Keywords provided by SuperSonic Imagine:
breast
lesion
ultrasound
BI-RADS
malignancy
women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 21, 2014