Clinical trial NCT00716482: Ultrasound Elastography of Breast Lesions
Official title: Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: breast
lesion
ultrasound
BI-RADS
malignancy
women
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 1681
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
timeFrame: performed on the same day, within 2 years from study start date
measure: Intraobserver Reliability of Quantitative SWE Measurements
timeFrame: performed on the same day, within 2 years from study start date
measure: Interobserver Agreement of B Mode Ultrasound and SWE Features
timeFrame: performed on the same day, after study completion
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California - LAC+USC Medical Center, OPD Rm 3P61
state: California
city: Denver
country: United States
facility: Sally Jobe Breast Center
state: Colorado
city: New Haven
country: United States
facility: Yale Medical Center, Department of Diagnostic Radiology
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Memorial Hospital, Dept. of Radiology
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center, Radiology
state: Massachusetts
city: Philadelphia
country: United States
facility: Thomas Jefferson Medical Center, Department of Radiology
state: Pennsylvania
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Marseille
country: France
facility: University Hospital La Timone
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Greifswald
country: Germany
facility: University Hospital, Frauenklinik
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Osnabrück
country: Germany
facility: Marienhospital, Klinik für Radiologie
city: Wiesbaden
country: Germany
facility: German Diagnostic Clinic
city: Gorizia
country: Italy
facility: Ospedale Civile di Gorizia
city: London
country: United Kingdom
facility: Charings Cross Hospital
Study officials:
affiliation: Hammersmith Hospitals NHS Trust
name: David O Cosgrove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.