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A single-center prospective clinical randomized controlled trial for indocyanine green replacement nuclide for sentinel lymph node combined development in breast cancer

A single-center prospective clinical randomized controlled trial for indocyanine green replacement nuclide for sentinel lymph node combined development in breast cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022938
Enrollment
Unknown
Registered
2019-05-04
Start date
2019-05-06
Completion date
Unknown
Last updated
2019-05-05

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

Conditions

Breast Cancer

Interventions

Sponsors

Southwest Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old; 2. histologically and/or cytologically confirmed breast cancer; 3. Initial treatment; no breast or axillary surgery before treatment; 4. Preoperative physical and auxiliary examination showed that the axillary fossa had no obvious structural abnormal swelling of the lymph nodes and no distant metastasis; 5. Patients must have the ability to understand and voluntarily sign informed consent; 6. ECOG physical status score is 0 to 2; 7. Subjects have no major organ dysfunction, laboratory test indicators must meet the following requirements: Hematology: white blood cells = 3.5 × 10^9/L, neutrophils = 2.0 × 10^9/L, platelet count = 100 × 10^9/L, hemoglobin = 95g/L; Liver function: serum bilirubin is less than 1.5 times the maximum normal value; ALT and AST are less than 1.5 times the maximum normal value. Renal function: creatinine clearance rate = 45mL / min; Heart function: Basically normal.

Exclusion criteria

Exclusion criteria: 1. patient had undergone surgery in the axillary region to destroy lymphatic drainage in this area; 2. Multi- or multi-focal breast cancer; 3. Axillary lymph node metastasis has been found clinically; 4. Patients with other system diseases or malignant tumors that cannot be operated ; 5. Breast cancer patients during pregnancy; 6. lactating breast cancer patients; 7. Researchers believe that other reasons are not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Sentinel lymph node detection rate;Sensitivity;False negative rate;Local and systemic side effects;Axillary recurrence;Distant metastasis;Survival situation;

Countries

China

Contacts

Public ContactXiaowei Qi

Southwest Hospital, Army Medical University

qxw9908@foxmail.com+86 13527545423

Outcome results

None listed

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