Ultrasound Elastography of Breast Lesions

NCT00716482 | Completed Results

• 1 other identifier: A00152-53
• Study Type: observational
• Target: 1,681
• Locations: 5 countries
• Sites: 16

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.

Conditions

Breast Neoplasms

Keywords

breast; lesion; ultrasound; BI-RADS; malignancy; women

Outcome Measures

Primary Outcomes (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

  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 Outcomes (3)

• Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature

  performed on the same day, within 2 years from study start date

• Intraobserver Reliability of Quantitative SWE Measurements

  performed on the same day, within 2 years from study start date

• Interobserver Agreement of B Mode Ultrasound and SWE Features

  performed on the same day, after study completion

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SuperSonic Imagine: lead

Study Sites (16)

University of Southern California - LAC+USC Medical Center, OPD Rm 3P61

Los Angeles, California, 90033, United States

Location

Sally Jobe Breast Center

Denver, Colorado, 80206, United States

Location

Yale Medical Center, Department of Diagnostic Radiology

New Haven, Connecticut, 06510, United States

Location

Northwestern Memorial Hospital, Dept. of Radiology

Chicago, Illinois, 60611, United States

Location

Boston Medical Center, Radiology

Boston, Massachusetts, 02118, United States

Location

Thomas Jefferson Medical Center, Department of Radiology

Philadelphia, Pennsylvania, 19107, United States

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

University Hospital La Timone

Marseille, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Institut Curie

Paris, France

Location

University Hospital, Frauenklinik

Greifswald, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

Marienhospital, Klinik für Radiologie

Osnabrück, Germany

Location

German Diagnostic Clinic

Wiesbaden, Germany

Location

Ospedale Civile di Gorizia

Gorizia, Italy

Location

Charings Cross Hospital

London, United Kingdom

Location

Related Publications (2)

• Cosgrove DO, Berg WA, Dore CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

  PMID: 22210408 RESULT

• Berg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.

  PMID: 22282182 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

* follow up on BI-RADS 2 lesions was not performed * operators knew the BI-RADS score of the lesion before performing SWE * more BI-RADS 3 and 4 lesions were recruited because of the study design

Results Point of Contact

• Title: Research Coordinator
• Organization: SuperSonic Imagine

sharon.bruce@supersonicimagine.fr

+33 442 99 24 24

Study Officials

• David O Cosgrove, MD

  Hammersmith Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 9, 2013
• Results First Posted: September 9, 2013

Record last verified: 2013-09

Locations

IT (1); DE (4); FR (4); US (6); GB (1)