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Completed

NCT Number: NCT02226081

ShearWave™ Elastography of Breast Lesions in Chinese Patients

We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

1st Affiliated Hospital of PLAGH (304), Beijing, China

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About this study

Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female
  • 18 years of age or older
  • known breast lesion that has not been managed or treated
  • referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:
  • physical palpation
  • mammography
  • ultrasound exam
  • MRI

Exclusion criteria

  • Women who are unwilling or unable to provide informed consent
  • Women with breast implants
  • Women who are pregnant or breastfeeding
  • Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6
  • Women with previous ipsilateral breast surgery
  • Women with no visible breast mass on ultrasound examination
  • Women with axillary metastatic lymph nodes only
  • Women with foreign body in the breast
  • Women who are not Chinese nationality

Treatment and study plan

Primary outcomes

  1. Increase in specificity of breast ultrasound imaging when considering stiffness measurements

    Time frame: Within 18 months of the study start date

Secondary outcomes

  1. Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements

    Time frame: Within 18 months of the study start date

  2. Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements

    Time frame: within 18 months of the study start date

Sponsors and collaborators

Lead sponsor

SuperSonic Imagine

Industry

Registry information

Official study title

Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients

Acronym: BE3

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2014
Registry last updated
Dec 20, 2018

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.

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