Breast Cancer
Conditions
Interventions
Standard treatment group:Double tracer sentinel lymph node biopsy (technetium 99, methylene blue)
Experimental group:Nanocarbon-labeled targeted lymph node excision and methylene blue tracing of sentinel lymph node biopsy
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, female; 2. Histologically diagnosed with invasive breast cancer (any subtype); 3.Clinical stage: cT1-3, N1-2, M0 (before neoadjuvant therapy); 4. Received standard neoadjuvant chemotherapy and endocrine therapy (NAT) regimen, with complete treatment course (as determined by the doctor to achieve the therapeutic goal); 5. After NAT, plans to undergo breast cancer surgery (lumpectomy or total mastectomy) and axillary sentinel lymph node biopsy (SLNB) or dissection (ALND); 6. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of allergy to nano-carbon, iodine agents or any dyes involved in the study; 2.Previous history of surgery on the same side axilla (such as lymph node biopsy, surgery); 3.Concurrent malignant tumors in other organs; 4. Inflammatory breast cancer; 5.Pregnant or lactating women; 6.Severe dysfunction of heart, liver or kidney, unable to tolerate surgery; 7.Unable to cooperate with the study follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The false negative rate of lymph node labeling with nano-carbon combined with methylene blue for tracing sentinel lymph nodes;The false negative rate of standard double-tracer sentinel lymph node biopsy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The detection rate of sentinel lymph nodes by axillary nano-carbon labeled lymph nodes combined with methylene blue tracing after neoadjuvant chemotherapy;The detection rate of traditional dual tracer (radioisotope and methylene blue) as the standard control;The difference in the detection of positive lymph nodes between targeted lymph node biopsy using nano-carbon and single tracer with blue dye versus traditional double tracer (in terms of detection rate, sensitivity, etc.);Incidence of adverse reactions (by type and severity); | — |
Countries
China
Contacts
Public ContactShi Aiping;Wu Di
The First Hospital of Jilin University
Outcome results
None listed