Clinical trial · Observational
ShearWave™ Elastography of Breast Lesions in Chinese Patients
Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
NCT02226081CI-TRIAL-00036226BE3completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Increase in specificity of breast ultrasound imaging when considering stiffness measurements
- timeFrame
- Within 18 months of the study start date
Secondary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLin 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. PMID 30349377