Sonographic localisation of lymph nodes suspicious of metastatic breast cancer to surgical axillary levels.
Michelle Fenech, Tracey Burke, Grace Arnett...
https://pubmed.ncbi.nlm.nih.gov/39552171Actively Recruiting
Age: 18Years +
FEMALE
ID07338721
Does Using Ultrasound Guidance During Axillary Incision Improve Sentinel Lymph Node Detection Compared to Standard Methods in Breast Cancer Patients?
Led by Antalya Training and Research Hospital · Updated on 2026-01-15
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates whether using ultrasound guidance to locate the first lymph node at the axillary entry can improve sentinel lymph node detection in breast cancer patients. The study aims to compare this ultrasound-guided incision with the conventional axillary hairline incision to see if it leads to smaller incisions, less tissue dissection, and shorter surgery times. Accurate assessment of axillary lymph nodes is crucial for planning breast cancer treatment, and sentinel lymph node biopsy is preferred due to lower complications compared to full lymph node removal. Participants are divided into two groups: one group receives an axillary incision guided by ultrasound targeting the first lymph node at the axillary entry, while the other group undergoes the standard incision below the axillary hairline. The ultrasound method allows direct access to the blue-stained sentinel lymph node, potentially reducing the need for extensive dissection and channel tracking. Both procedures are assessed during the sentinel lymph node biopsy. During the study, researchers will evaluate surgical performance during the sentinel lymph node procedure, focusing on operative time and tissue dissection extent. Participants will be monitored intraoperatively to assess these surgical outcomes. The trial includes women aged 18 and older with specific breast cancer stages and no distant metastasis, and it continues until the sentinel lymph node procedure is complete.
CONDITIONS
Brief Title
Does Ultrasound Guidance Axillary Incision Improve Sentinel Lymph Node Detection in Breast Cancer?
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Patients with clinical stage T1-T3 breast cancer (tumor 64 5 cm), pN0-pN1 (one to three lymph nodes with micrometastases or metastases), and M0 (no distant metastasis) are eligible.
- Patients with post-neoadjuvant yT1-T3, yN0-yN1, and M0 status are also eligible.
- Patients must have a clinically negative axilla.
- All patients must be undergoing axillary staging.
- Written informed consent must be obtained prior to inclusion.
You will not qualify if you...
- Younger than 18 years.
- Previous breast malignancy.
- Pregnancy.
- Pre-operative diagnosis of axillary lymph node metastases.
- Presence of multiple clinically involved or suspicious lymph nodes.
- Unable or unwilling to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo axillary incision surgery using either ultrasound guidance or the standard method for sentinel lymph node biopsy, followed by immediate post-operative care.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to several weeks after surgery
Participants are monitored after surgery to assess recovery and surgical outcomes.
Approximately 1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Antalya Training and Research Hospital
Antalya, Turkey (Türkiye), 07100
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
The lymphatic anatomy of the breast and its implications for sentinel lymph node biopsy: a human cadaver study.
Hiroo Suami, Wei-Ren Pan, G Bruce Mann...
https://pubmed.ncbi.nlm.nih.gov/18043970Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial.
Oreste Davide Gentilini, Edoardo Botteri, Claudia Sangalli...
https://pubmed.ncbi.nlm.nih.gov/37733364Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes.
U Veronesi, G Paganelli, V Galimberti...
https://pubmed.ncbi.nlm.nih.gov/9217757Anatomy and physiology of lymphatic drainage of the breast from the perspective of sentinel node biopsy.
P J Tanis, O E Nieweg, R A Valdés Olmos...
https://pubmed.ncbi.nlm.nih.gov/11245383