ShearWave™ Elastography of Breast Lesions in Chinese Patients

NCT ID: NCT02226081

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Neoplasms

Keywords

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breast lesion ultrasound BI-RADS women malignancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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SuperSonic Imagine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cai Chang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Anhua Li

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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1st Affiliated Hospital of PLAGH (304)

Beijing, , China

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status

People's Liberation Army General Hospital (301)

Beijing, , China

Site Status

Affiliated Hospital of Binzhou Medical University

Binzhou, , China

Site Status

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

Fujian Provincial Cancer Hospital

Fuzhou, , China

Site Status

Guangdong Provincial Traditional Chinese Medical Hospital

Guangzhou, , China

Site Status

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, , China

Site Status

Sun-Yat Sen University Cancer Center

Guangzhou, , China

Site Status

1st Affiliated Hospital of Harbin University

Harbin, , China

Site Status

Hefei 2nd People's Hospital

Hefei, , China

Site Status

Jiangsu Provincial Hospital

Nanjing, , China

Site Status

Yinzhou People's Hospital

Ningbo, , China

Site Status

Fudan University Cancer Center

Shanghai, , China

Site Status

1st Affiliated Hospital of China Medical University

Shenyang, , China

Site Status

4th Affiliated Hospital of China Medical University

Shenyang, , China

Site Status

Shengjing Hospital of China Medical University

Shenyang, , China

Site Status

General Hospital of TISCO

Taiyuan, , China

Site Status

Shanxi Dayi Hospital

Taiyuan, , China

Site Status

1st Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

1st Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 30349377 (View on PubMed)

Related Links

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Other Identifiers

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ChiCTR-DDT-14004785

Identifier Type: REGISTRY

Identifier Source: secondary_id

BE3

Identifier Type: -

Identifier Source: org_study_id