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Multi center study of ultrasonic strain elastography and two-dimensional shear wave elastography in differentiating benign and malignant breast nodules

Multi center study of ultrasonic strain elastography and two-dimensional shear wave elastography in differentiating benign and malignant breast nodules

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050879
Enrollment
Unknown
Registered
2021-09-05
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Breast nodule

Interventions

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. There is one or more definite breast nodules; 2. Aged over 18 years; 3. Conventional BI-RADS classification class 3 and above; 4. Patients who are about to undergo breast mass biopsy or surgical resection.

Exclusion criteria

Exclusion criteria: 1. Suffering from diseases that are unfavorable to the test or pose a threat to other selected persons, such as mental diseases; 2. Unable to cooperate with the test operation; 3. Pregnant or lactating women; 4. The quality of ultrasonic image is poor, which can not meet the requirements of parameter measurement and analysis; 5. History of breast surgery or breast biopsy; 6. CNB or surgical pathological results could not be obtained after examination; 7. No clear diagnosis of benign and malignant was obtained after puncture or operation; 8. Simple cystic nodule and calcification; 9. The basic information is incomplete.

Design outcomes

Primary

MeasureTime frame
Strainelastography(SE);Two-dimensional Shear Wave Elastography;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactHe Nian'an

The First Affiliated Hospital of University of Science and Technology of China

henianan71@qq.com+86 18900518346

Outcome results

None listed

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