Ultrasound Elastography of Breast Lesions

Completed

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.

Recruitment & Eligibility

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 Outcome Measures

Name	Time	Method
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	2 years	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

Name	Time	Method
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature	performed on the same day, within 2 years from study start date	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	performed on the same day, within 2 years from study start date	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	performed on the same day, after study completion	614 benign and 144 malignant breast masses.

Locations (16): Yale Medical Center, Department of Diagnostic Radiology
🇺🇸
New Haven, Connecticut, United States
Marienhospital, Klinik für Radiologie
🇩🇪
Osnabrück, Germany
Centre Antoine Lacassagne
🇫🇷
Nice, France
Ospedale Civile di Gorizia
🇮🇹
Gorizia, Italy
Charings Cross Hospital
🇬🇧
London, United Kingdom
University Hospital La Timone
🇫🇷
Marseille, France
University of Southern California - LAC+USC Medical Center, OPD Rm 3P61
🇺🇸
Los Angeles, California, United States
Boston Medical Center, Radiology
🇺🇸
Boston, Massachusetts, United States
Institut Curie
🇫🇷
Paris, France
University Hospital Schleswig-Holstein
🇩🇪
Kiel, Germany
Thomas Jefferson Medical Center, Department of Radiology
🇺🇸
Philadelphia, Pennsylvania, United States
Hôpital Privé Jean Mermoz
🇫🇷
Lyon, France
German Diagnostic Clinic
🇩🇪
Wiesbaden, Germany
University Hospital, Frauenklinik
🇩🇪
Greifswald, Germany
Sally Jobe Breast Center
🇺🇸
Denver, Colorado, United States
Northwestern Memorial Hospital, Dept. of Radiology
🇺🇸
Chicago, Illinois, United States