Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

David O Cosgrove, MD

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.

Ultrasound Elastography of Breast Lesions

Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

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.

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.

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.

614 benign and 144 malignant breast masses.

SuperSonic Imagine

Adverse Events were not collected as a part of this study.

B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination

Breast Lesion

Age Continuous

Sex: Female, Male

France

United States

Germany

Italy

United Kingdom

Region of Enrollment

There were 1681 "started" participants and 1562 "completed" participants. Reasons for rejected participants are listed in "participant flow" section

* follow up on BI-RADS 2 lesions was not performed
* operators knew the BI-RADS score of the lesion before performing SWE
* more BI-RADS 3 and 4 lesions were recruited because of the study design

Research Coordinator

Null hypothesis is that there is no difference between the two tests.

Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).

Null hypothesis is that there is no difference between the two tests.

Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).

Null hypothesis is that there is no difference between the two tests.

Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).

Null hypothesis is that there is no difference between the two tests.

Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).

Null hypothesis is that there is no difference between the two tests.

Elastography image median mean elasticity value.

Null hypothesis is that there is no difference between the two tests.

Elastography image diameter ratio.

Null hypothesis is that there is no difference between the two tests.

Elastography image median elasticity ratio.

Null hypothesis is that there is no difference between the two tests.

Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).

Null hypothesis is that there is no difference between the two tests.

Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).

Null hypothesis is that there is no difference between the two tests.

Elastography image lesion shape.

Null hypothesis is that there is no difference between the two tests.

Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).

Null hypothesis is that there is no difference between the two tests.

Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).

Null hypothesis is that there is no difference between the two tests.

Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).

Null hypothesis is that there is no difference between the two tests.

Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).

Null hypothesis is that there is no difference between the two tests.

Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).

Null hypothesis is that there is no difference between the two tests.

Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).

Null hypothesis is that there is no difference between the two tests.

lesion shape

lesion homogeneity-conservative strategy

lesion homogeneity-aggressive strategy

maximum elasticity (Emax)-conservative strategy

maximum elasticity (Emax)-aggressive strategy

median mean elasticity (Emean)

diameter ration (Edia)

median elasticity ratio (Erat)

color score of Emax (Ecol)-conservative strategy

color score of Emax (Ecol)-aggressive strategy

Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination

Specificity

Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination

Sensitivity

Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.

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

Null hypothesis: no variance of similarity exists between the three groups

All images very or reasonably similar

Some images similar

Images very dissimilar

The Elastography image of the lesion has a smooth and consistent color appearance throughout, or very subtle color differences relating to small changes on the color scale are observed.

Very Homogeneous

The Elastography image of the lesion has a slightly "patchy" appearance. The image may consist of larger (2-5mm) sub-regions within the lesion boundary that are homogenous, or the color differences between adjacent areas within the lesion are small.

Reasonably Homogeneous

The Elastography image of the lesion is inhomogeneous and has a "mottled" or "patchy" appearance throughout.

Not Homogeneous

Per protocol. One lesion was analyzed per participant.

Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature

Diameter

Area

Perimeter

E minimum mass

E maximum mass

E mean mass

E ratio (mass:fat)

E minumum fat

E maximum fat

E mean fat

Overall (All Masses)

Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.

Intraobserver Reliability of Quantitative SWE Measurements

B-mode shape

B-mode orientation

B-mode margin

B-mode BI-RADS assessment

SWE shape

SWE homogeneity

SWE Emax

Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.

Spots Global Cancer Trial Database for Ultrasound Elastography of Breast Lesions

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial