Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR-DDT-14004785 | Registry Identifier | China Clinical Trial |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Increase in specificity of breast ultrasound imaging when considering stiffness measurements | Within 18 months of the study start date |
| Measure | Description | Time Frame |
|---|---|---|
| Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements | Within 18 months of the study start date | |
| Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cai Chang | Fudan University | Principal Investigator |
| Anhua Li | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Affiliated Hospital of PLAGH (304) | Beijing | China | ||||
| Beijing Friendship Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30349377 | Result | 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. |
| Label | URL |
|---|---|
| Full-length article in Cancer Management and Research journal | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| within 18 months of the study start date |
| Beijing |
| China |
| People's Liberation Army General Hospital (301) | Beijing | China |
| Affiliated Hospital of Binzhou Medical University | Binzhou | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| West China Hospital, Sichuan University | Chengdu | China |
| Fujian Provincial Cancer Hospital | Fuzhou | China |
| Guangdong Provincial Traditional Chinese Medical Hospital | Guangzhou | China |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | China |
| Sun-Yat Sen University Cancer Center | Guangzhou | China |
| 1st Affiliated Hospital of Harbin University | Harbin | China |
| Hefei 2nd People's Hospital | Hefei | China |
| Jiangsu Provincial Hospital | Nanjing | China |
| Yinzhou People's Hospital | Ningbo | China |
| Fudan University Cancer Center | Shanghai | China |
| 1st Affiliated Hospital of China Medical University | Shenyang | China |
| 4th Affiliated Hospital of China Medical University | Shenyang | China |
| Shengjing Hospital of China Medical University | Shenyang | China |
| General Hospital of TISCO | Taiyuan | China |
| Shanxi Dayi Hospital | Taiyuan | China |
| 1st Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| 1st Affiliated Hospital of Zhengzhou University | Zhengzhou | China |