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Indocyanine green substitute nuclide for sentinel lymph node combined development in breast cancer: a single-center prospective self-controlled clinical study

Indocyanine green substitute nuclide for sentinel lymph node combined development in breast cancer: a single-center prospective self-controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030729
Enrollment
Unknown
Registered
2020-03-12
Start date
2020-03-02
Completion date
Unknown
Last updated
2020-03-16

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) Age: 18-70 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 examinations showed that the axillary fossa had no obvious structural abnormal swelling of the lymph nodes and no distant metastasis; 5) Patients who voluntarily receive three tracers of SLN; 6) Patients must have the ability to understand and voluntarily sign the informed consent; 7) ECOG physical status score is 0 to 2; 8) Subjects have no major organ dysfunction, laboratory test indicators must meet the following requirements: Hematology: WBC >= 3.5 x 10^9/L, neutrophils >= 2.0 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 95g/L. Liver function: serum bilirubin was 1.5 times lower than the maximum normal value; ALT and AST are 1.5 times lower than maximum normal. 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) Breast cancer patients during pregnancy; 5) Lactating breast cancer patients; 6) Patients with other system diseases or malignant tumors that cannot be operated; 7) Researchers believe that other reasons are not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Sentinel lymph node detection rate;Local and systemic side effects;Sensitivity;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