Ultrasound Elastography of Breast Lesions

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Privé Jean Mermoz, Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Time frame: 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 outcomes

Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature

Time frame: 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

Time frame: 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

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

614 benign and 144 malignant breast masses.

Sponsors and collaborators

Lead sponsor

SuperSonic Imagine

Industry

Registry information

Official study title

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

Acronym: BE1

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jul 16, 2008
Registry last updated: Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed