Ultrasound Elastography of Breast Lesions

SuperSonic Imagine1,681 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,681

Conditions

Breast Neoplasms

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (16)

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

Los Angeles, California, United States

Sally Jobe Breast Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature

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.

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

Intraobserver Reliability of Quantitative SWE Measurements

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.

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

Interobserver Agreement of B Mode Ultrasound and SWE Features

614 benign and 144 malignant breast masses.

Time frame: performed on the same day, after study completion

Data from ClinicalTrials.gov

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