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A multi-center study of breast contrast-enhanced ultrasound in the diagnosis of BI-RADS 4A lesions

A multi-center study of breast contrast-enhanced ultrasound in the diagnosis of BI-RADS 4A lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050719
Enrollment
Unknown
Registered
2021-09-03
Start date
2021-10-08
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

BIRADS 4A breast lesions

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged 18~70 years; 2. Conventional ultrasonic detection of breast tumor of BI-RADS 4A lesions, the maximum diameter of the lesion was 0.5-2cm (the size of lesions is too tiny to show dynamic enhancement features; the lesion volume is too huge to show dynamic enhancement features completely in dual display mode, while Larger lesions, patients have a relatively strong desire for clinical intervention).

Exclusion criteria

Exclusion criteria: 1. Pregnant/lactating mother, or people with cardiopulmonary anomaly; 2. Patients not suitable for breast contrast-enhanced ultrasound; 3. Patients without pathological report; 4. Patients refuse contrast-enhanced ultrasonography;Non-mass image-forming breast lesions; 5. Be allergy to egg products. 6. Dynamic observation showed that the lesions were patients with fusion of multiple lesions; 7. Patients whose lesions have undergone interventional diagnosis / treatment or whose lesions are located in the quadrant with previous surgical history.

Design outcomes

Primary

MeasureTime frame
Enhancement patterns of the contrast-enhanced ultrasound;SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Countries

CHINA

Contacts

Public ContactLuo Baoming

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

bmluo2005@126.com+86 13602728295

Outcome results

None listed

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