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Study on the Application of Multimodal Ultrasound in Differentiating Benign and Malignant Breast Masses and Reassessing BI-RADS 4 Breast Nodules

Study on the Application of Multimodal Ultrasound in Differentiating Benign and Malignant Breast Masses and Reassessing BI-RADS 4 Breast Nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123256
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Benign and malignant breast masses

Interventions

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female, aged 18 years and above; 2.Imaging examination of the breast mass suggests further evaluation is needed; breast surgery or histopathological examination is planned; 3.Preoperative completion of standardized multimodal ultrasound examinations (including B-mode ultrasound, elastography, CDFI, contrast-enhanced ultrasound, etc., with clear image quality); 4.complete pathological results; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Image data is missing or image quality does not meet analysis requirements; 2.Those who have received neoadjuvant therapy, radiotherapy, or other interventions that may affect the original morphology of the lesion; 3.Patients with unclear pathological results or missing follow-up data; 4.Combined with primary malignant tumors of other sites; 5.Pregnant or breastfeeding women; 6. Those who refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Contrast enhanced-ultrasound;AUC, accuracy, sensitivity, specificity;

Countries

China

Contacts

Public ContactHan Wu

The Second Affiliated Hospital of Harbin Medical University

wuhan181015@126.com+86 451 86605925

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026