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A single-center, single-blinded, randomized, parallel-group, superiority study to compare the effecttiveness of subcutaneous injection with Sonazoid to detect axillary sentinel lymph node versus SonoVue in the female with breast tumor (SZ-SV DBCASN)

A single-center, single-blinded, randomized, parallel-group, superiority study to compare the effecttiveness of subcutaneous injection with Sonazoid to detect axillary sentinel lymph node versus SonoVue in the female with breast tumor (SZ-SV DBCASN)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095604
Enrollment
Unknown
Registered
2025-01-09
Start date
2025-06-03
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

The axillary sentinel lymph nodes of breast cancer

Interventions

Experimental group:Transareolar subcutaneous injection of Sonazoid
Control group:Transareolar subcutaneous injection of SonoVue

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients who meet the trial conditions must comply with all of the following requirements when randomly grouped: 1.Adult female (aged 18 or above); 2. The breast mass is classified as BI-RADS 4a or above.

Exclusion criteria

Exclusion criteria: 1.Subjects who have been diagnosed with breast cancer and have received radiotherapy, chemotherapy or endocrine suppression therapy; 2. There is an abscess on the skin near the nipples; 3. Severe ulceration of the skin in the nipple and areola areas, with no normal skin available for drug injection; 4. Pregnant women (with negative blood HCG test results) and lactating women; 5. Those who suffer from personality or mental disorders and have no or limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
Detection rate of axillary sentinel lymph nodes;

Secondary

MeasureTime frame
Adverse reactions to contrast agents;Accuracy of percutaneous contrast-enhanced ultrasound in diagnosing axillary sentinel lymph nodes;

Countries

China

Contacts

Public ContactFengping Liang

The Seventh Affiliated Hospital, Sun Yat-sen University

liangfp@mail.sysu.edu.cn+86 755 8120 6581

Outcome results

None listed

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