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Extended Sentinel Lymph Node Biopsy With Methylene Blue Single Tracer Post-Neoadjuvant Therapy for Node-Positive Breast Cancer

NCT07532096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-15

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and feasibility of methylene blue single tracer-based extensive sentinel lymph node biopsy (ESLNB) and provide evidence for simplifying surgical procedures on the basis of ensuring axillary safety, as well as clarify the incidence of postoperative upper limb lymphedema in female patients with axillary node-positive breast cancer who achieve clinical axillary node negativity after neoadjuvant therapy. The main questions it aims to answer are:

* What is the false negative rate of methylene blue single tracer-based extensive sentinel lymph node biopsy in the above-mentioned breast cancer patients?
* What are the false negative rate and detection rate of methylene blue single tracer-based conventional sentinel lymph node biopsy
* What is the incidence of upper limb lymphedema within 2 years after surgery in these patients?

Participants will:

* Undergo strict screening to confirm eligibility for the trial and sign an informed consent form
* Receive a complete standard neoadjuvant therapy for 6 or 8 cycles as required
* Undergo personalized breast surgery combined with methylene blue single tracer-based ESLNB plus axillary lymph node dissection
* Accept pathological evaluation of the number of lymph nodes and metastatic lymph nodes in each resected part after surgery
* Receive adjuvant therapies such as targeted therapy, endocrine therapy or local radiotherapy in accordance with clinical guidelines
* Complete regular follow-up for 2 years after surgery (once every 6 months), including physical sign checks, surgical site evaluations, and upper limb circumference measurements to assess lymphedema

Conditions

Interventions

PROCEDURE

ESLNB

First, personalized breast surgery is performed in accordance with the patient's breast tumor condition (e.g., breast-conserving surgery, modified radical mastectomy). Next, blue-stained lymphatic vessels are dissected and identified to locate and resect the primary sentinel lymph nodes (SLNs). Subsequently, the lymphoid tissue in the extensive sentinel lymph node region (2-3cm around the resected SLNs) is completely excised (defined as ESLNB in this study). Finally, systematic dissection and clearance of the remaining axillary lymph node regions are conducted to complete ALND. Post-surgical wound management: The surgical wound is rinsed and soaked successively with sterile distilled water and normal saline for hemostasis; a drainage tube is placed, and the skin is sutured layer by layer in accordance with standard surgical protocols.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2027-05-01
Completion
2028-05-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07532096 on ClinicalTrials.gov