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Diagnostic value of shear wave elastography combined with contrast-enhanced ultrasound in BI-RADS 4 breast lesions

Diagnostic value of shear wave elastography combined with contrast-enhanced ultrasound in BI-RADS 4 breast lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050604
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-08-30
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast lesions

Interventions

Gold Standard:pathological diagnosis
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contrast-enhanced&#32
ultrasound&#32

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient is a female patient, aged 18 to 80 years, who is admitted to the breast department or other clinical department of the hospital. 2. The diagnosis of breast BI-RADS class 4 nodules by imaging examination in our hospital or a tertiary hospital of the same level; 3. The diameter of the nodule is less than 30mm (due to the limitation of the size of the SWE sampling frame); 4. Be informed about the study, sign an informed consent form, and voluntarily accept shear wave elastography and contrast-enhanced ultrasound examinations; 5. Those who are assessed as having a high malignant tendency agree and cooperate with needle biopsy, rotational biopsy or surgical treatment, and finally obtain a pathological diagnosis; 6. No acute coronary syndrome or clinically unstable ischemic heart disease symptoms have occurred recently.

Exclusion criteria

Exclusion criteria: 1. Incomplete clinical and pathological data; 2. After breast augmentation, during pregnancy or breastfeeding; 3. The target mass has undergone invasive operations such as radiotherapy and chemotherapy or puncture and resection; 4. There is a history of adverse reactions with the use of sulfur hexafluoride or phospholipids; 5. Have a history of asthma, urticaria, etc.; 6. History of malignant tumor and other cachexia patients.

Design outcomes

Primary

MeasureTime frame
imaging index;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactZhang Bo

Xiangya Hospital of Central South University

zhangbo8095@126.com+86 13975888095

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026