Subharmonic Imaging of Early-stage Breast Cancer for Preoperative Prediction of Axillary Lymph Node Metastasis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000032939

Enrollment

Unknown

Registered

2020-05-16

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-05-18

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:Sentinel lymph node biopsy or axillary lymph node dissection, pathological examination

Index test:subharmonic imaging

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) BI-RADS category higher or equal to 4A breast lessions; (2) The largest diameter of breast lesion between 0.5 to 3cm and depth less than 4cm; (3) Females equal to or older than 18 years old; (4) Sign the written informed consent.

Exclusion criteria

Exclusion criteria: (1) Female during pregnancy and latation; (2) No breast lesions detected by ultrasound; (3) Previous surgery or implants of ipsilateral breast; (4) Previous radiotherapy or chemotherapy; (5) Refuse biopsy or surgery; (6) An advanced case.

Design outcomes

Primary

Measure	Time frame
AUC of ROC;sensitivity, specitivity, negative predictive value, positive predictive value;	—

Countries

China

Contacts

Public ContactJianhua Zhou

Sun Yat-sen University Cancer Center

zhoujh@sysucc.org.cn+86 13711757623

Outcome results

None listed

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