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Ultrasound Elastography of Breast Lesions

NCT ID: NCT00716482

Last Updated: 2013-09-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1681 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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breast lesion ultrasound BI-RADS malignancy women

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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SuperSonic Imagine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David O Cosgrove, MD

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Hospitals NHS Trust

Locations

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

Los Angeles, California, United States

Site Status

Sally Jobe Breast Center

Denver, Colorado, United States

Site Status

Yale Medical Center, Department of Diagnostic Radiology

New Haven, Connecticut, United States

Site Status

Northwestern Memorial Hospital, Dept. of Radiology

Chicago, Illinois, United States

Site Status

Boston Medical Center, Radiology

Boston, Massachusetts, United States

Site Status

Thomas Jefferson Medical Center, Department of Radiology

Philadelphia, Pennsylvania, United States

Site Status

Hôpital Privé Jean Mermoz

Lyon, , France

Site Status

University Hospital La Timone

Marseille, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Institut Curie

Paris, , France

Site Status

University Hospital, Frauenklinik

Greifswald, , Germany

Site Status

University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

Marienhospital, Klinik für Radiologie

Osnabrück, , Germany

Site Status

German Diagnostic Clinic

Wiesbaden, , Germany

Site Status

Ospedale Civile di Gorizia

Gorizia, , Italy

Site Status

Charings Cross Hospital

London, , United Kingdom

Site Status

Countries

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United States France Germany Italy United Kingdom

References

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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.

Reference Type RESULT
PMID: 22210408 (View on PubMed)

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.

Reference Type RESULT
PMID: 22282182 (View on PubMed)

Other Identifiers

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A00152-53

Identifier Type: -

Identifier Source: org_study_id