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Prospective Study of Sonazoid Contrast-enhanced Ultrasound in the Assessment of Axillary Lymph Node Metastasis in Early Breast Cancer

Prospective Study of Sonazoid Contrast-enhanced Ultrasound in the Assessment of Axillary Lymph Node Metastasis in Early Breast Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080297
Enrollment
Unknown
Registered
2024-01-25
Start date
2021-12-27
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Breast cancer

Interventions

Gold Standard:Surgical pathological diagnosis or biopsy pathological diagnosis.
Index test:Sonazoid Contrast-enhanced Ultrasound

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age greater than or equal to 18 years old. 2) Available to choose the diagnosis and treatment method independently, and obtain the signing of the informed consent form. 3) Patients with T1/2 stage breast cancer that have been pathologically diagnosed. 4) Patients classified as 4C or 5 by ultrasound BI-RADS. 5) Axillary lymph nodes can be confirmed pathologically.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women. 2) Patients with contraindications for Sonazoid contrast-enhanced ultrasonography. 3) Patients with contraindications for both CT and MRI. 4) Patients who cannot tolerate surgery or puncture. 5) Patients whose biopsy results are not breast cancer. 6) Patients with unstable clinical status, advanced disease or unpredictable clinical course. 7) Patients with a history of breast cancer or other malignant tumors. 8) Patients who have received the study drug within 30 days before the contrast-enhanced ultrasound or need to receive the study drug within 72 hours after the contrast-enhanced ultrasound.

Design outcomes

Primary

MeasureTime frame
Ultrasound appearance;

Secondary

MeasureTime frame
Sensitivity;Positive predictive value;

Countries

China

Contacts

Public ContactJianhua Zhou

Sun Yat-sen University Cancer Center

Zhoujh@sysucc.org.cn+86 137 1175 7623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026