Observational study of ultrasound microbubbles combined with methylene blue in sentinel lymph node imaging in breast cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400092454

Enrollment

Unknown

Registered

2024-11-18

Start date

2023-05-10

Completion date

Unknown

Last updated

2024-12-02

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

Conditions

Breast

Interventions

Gold Standard:Pathological section

Index test:Ultrasound enhanced signal and visible blue with the naked eye

Eligibility

Sex/Gender

All

Age

20 Years to 95 Years

Inclusion criteria

Inclusion criteria: ? Preoperative physical examination found that there were negative axillary lymph nodes palpated; ? Primary breast cancer with clinical stage I or II; ? Patients who did not receive neoadjuvant chemoradiotherapy; ? no previous history of axillary surgery; (5) Ultrasound, molybdenum target, CT, MRI and other examinations did not find tumor metastasis to distant patients; ? Patients and their families sign informed consent forms.

Exclusion criteria

Exclusion criteria: ? Patients with inflammatory breast cancer; ? Previous history of breast or axillary surgery; ? Pregnant or lactating patients; ? preoperative biopsy positive; ? Patients with other malignant tumors

Design outcomes

Primary

Measure	Time frame
Blue stained lymph nodes;Accuracy;Sensitivity;Specificity;	—

Secondary

Measure	Time frame
Positive predicative value;Negative predictive value;	—

Countries

China

Contacts

Public ContactHe peng

Affiliated Hospital of North Sichuan Medical College

xiaoxich@qq.com+86 182 9195 6318

Outcome results

None listed

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