Clinical trial NCT02226081: ShearWave™ Elastography of Breast Lesions in Chinese Patients
Official title: Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: breast lesion
ultrasound
BI-RADS
women
malignancy
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
First posted: 2014-08-26
Enrollment: 2273
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in specificity of breast ultrasound imaging when considering stiffness measurements
timeFrame: Within 18 months of the study start date
Secondary outcomes:
measure: Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements
timeFrame: Within 18 months of the study start date
measure: Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements
timeFrame: within 18 months of the study start date
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1st Affiliated Hospital of PLAGH (304)
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: People's Liberation Army General Hospital (301)
city: Binzhou
country: China
facility: Affiliated Hospital of Binzhou Medical University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial Traditional Chinese Medical Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
city: Guangzhou
country: China
facility: Sun-Yat Sen University Cancer Center
city: Harbin
country: China
facility: 1st Affiliated Hospital of Harbin University
city: Hefei
country: China
facility: Hefei 2nd People's Hospital
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
city: Ningbo
country: China
facility: Yinzhou People's Hospital
city: Shanghai
country: China
facility: Fudan University Cancer Center
city: Shenyang
country: China
facility: 1st Affiliated Hospital of China Medical University
city: Shenyang
country: China
facility: 4th Affiliated Hospital of China Medical University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Taiyuan
country: China
facility: General Hospital of TISCO
city: Taiyuan
country: China
facility: Shanxi Dayi Hospital
city: Xi'an
country: China
facility: 1st Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: 1st Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Fudan University
name: Cai Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Anhua Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.