CompletedNot Applicable

Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for CN+ Breast Cancer

China159 participantsStarted 2020-09-24

Plain-language summary

To explore the feasibility of target biopsy of carbon nanoparticles labelled lymph node after neoadjuvant systemic therapy for cN+ breast cancer, and evaluate whether it can accurately predict axillary lymph node status after neoadjuvant systemic therapy.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. Female breast cancer patients who received neoadjuvant systemic chemotherapy, aged 18-70 years old, with clinically assessed positive lymph node, and the expected survival period is greater than 12 months.
✓. No previous radiotherapy and chemotherapy.
✓. No history of serious systemic disease.
✓. KPS≥70.
✓. White blood cell count\> 3.5 × 10 \^ 9 / L, neutrophil count\> 1.8 × 10 \^ 9 / L, platelet count\> 100 × 10 \^ 9 / L, hemoglobin\> 9 g / dl.
✓. ALT and AST \<1.5 times the upper limit of normal value, alkaline phosphatase \<2.5 times the upper limit of normal value, and total bilirubin \<1.5 times the upper limit of normal value.
✓. Serum muscle plasma \<1.5 times the upper limit of normal value.
✓. No abnormal blood coagulation.

Exclusion criteria

✕. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy and endocrine therapy.
✕. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
✕. The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
✕. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression and other diseases, can not tolerate chemotherapy related treatments.

What they're measuring

The accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes

Timeframe: 1-3 day before NST, the suspected lymph nodes will be injected carbon nanoparticle. During operation, carbon nanoparticle labelled lymph nodes will be identified and sent for examination.

Trial details

NCT IDNCT04482803

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-02

View on ClinicalTrials.gov More Location and Biopsy of Axillary Lymph Nodes trials