Ultrasound Elastography of Breast Lesions - Full Text View

Sponsor:	SuperSonic Imagine
Information provided by:	SuperSonic Imagine
ClinicalTrials.gov Identifier:	NCT00716482

Purpose

Our hypothesis is that the addition of shear wave Elastography 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:	Case-Only, 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by SuperSonic Imagine:

Primary Outcome Measures:

Assess the potential value of adding shear wave Elastography to a conventional ultrasound exam while imaging breast lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2300
Study Start Date:	July 2008

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	Completed
Los Angeles, California, United States, 90033
United States, Colorado
Sally Jobe Breast Center	Completed
Denver, Colorado, United States, 80206
United States, Connecticut
Yale Medical Center, Department of Diagnostic Radiology	Completed
New Haven, Connecticut, United States, 06510
United States, Illinois
Northwestern Memorial Hospital, Dept. of Radiology	Completed
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston Medical Center, Radiology	Completed
Boston, Massachusetts, United States, 02118
United States, Pennsylvania
Thomas Jefferson Medical Center, Department of Radiology	Completed
Philadelphia, Pennsylvania, United States, 19107
France
Institut Curie	Completed
Paris, France
Centre Antoine Lacassagne	Completed
Nice, France
University Hospital La Timone	Recruiting
Marseille, France
Contact: Valerie Juhan, MD +33 4.91.38.46.53
Principal Investigator: Valerie Juhan, MD
Sub-Investigator: Anne Colavolpe, MD
Hôpital Privé Jean Mermoz	Completed
Lyon, France
Germany
German Diagnostic Clinic	Completed
Wiesbaden, Germany
University Hospital, Frauenklinik	Completed
Greifswald, Germany
Marienhospital, Klinik für Radiologie	Recruiting
Osnabrück, Germany
Contact: Alexander Mundinger 00 49 541 326 4452
Principal Investigator: Alexander Mundinger, MD
University Hospital Schleswig-Holstein	Recruiting
Kiel, Germany
Contact: Ingrid Schreer, Prof. Dr. +49 431 597 2169
Principal Investigator: Ingrid Schreer, Prof. Dr.
Sub-Investigator: Fritz Schäfer, MD
Italy
Ospedale Civile di Gorizia	Recruiting
Gorizia, Italy
Contact: Martina Locatelli, MD martiloc@yahoo.it
United Kingdom
Charings Cross Hospital	Recruiting
London, United Kingdom
Contact: Nicola Ferreira 00 44 020 8383 0788 Nicola.Ferreira@imperial.nhs.uk
Principal Investigator: David O Cosgrove, MD
Sub-Investigator: William Svensson, MD

Sponsors and Collaborators

SuperSonic Imagine

Investigators

Principal Investigator:

David O Cosgrove, MD

Hammersmith Hospital, London, UK

More Information

No publications provided

Responsible Party:	SuperSonic Imagine ( Sharon Bruce/Clinical Research Coordinator )
Study ID Numbers:	A00152-53
Study First Received:	July 14, 2008
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00716482 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010