Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients.

Detailed Description
-----------------
Various markers has been used for SLN biopsy including isosulfan blue (patent blue), indocyanine green (ICG), radioisotope colloid (RAIC) and ultrasound (US) with several advantages and disadvantages. In this study investigators designed an algorithm using the combination of mapping with patent blue, ICG, RAIC and US to compare the accurate identification of SLN in breast cancer patients. The protocol is based on the hypothesis that identification rate of SLN is increased with multiple agents. Patent blue and ICG provides visual guidance. The combination of dyes with sonographic and RAIC method have the potential to prevent obstacles and ensure better outcomes as an identification strategy. Patent blue provides visual identification of the SLN. ICG fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. RAI has several advantages, but disadvantages as well, like cost and invisibility. RAI can only be detected and confirmed by means of sound and numerical value through gamma probe. All breast cancer patients underwent axillary ultrasound before SLNB with different mapping combinations. The determination of abnormal axillary lymph node was followed by ultrasound-guided FNA cytology of these nodes. The sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness >2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). Patients with negative results of FNA would undergo SLNB. Lymphatic mapping was performed with abovementioned dyes and radioactive colloid. Before the incising for SLNB real time intraoperative US was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. In the SLNB operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.

Official Title
-----------------
The Comparative Analysis of Multimodal Markers to Identify Sentinel Lymph Node in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Sentinel lymph node biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy cN0 patients In patients with abnormal axillary lymph nodes sonographically US-guided FNA cytology of these nodes were performed and FNA cytology negative patients planed to undergo SLNB with different mapping techniques. Exclusion Criteria: Patients with neoadjuvant therapy Patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy Patients with pathologically proven axillary disease Patients with T4d tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-center, randomized study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RAI+PB+US<br>Sentinel lymph node mapping with dual tracer (radioisotope and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.<br>|
| Experimental: RAI+ICG+US<br>Sentinel lymph node mapping with dual tracer (radioisotope and ICG) and intraoperative ultrasound to identify SLN in the breast cancer patients | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.<br>|
| Experimental: RAI+PB+ICG+US<br>Sentinel lymph node mapping with triple tracer (radioisotope,ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.<br>|
| Experimental: PB+ICG+US<br>Sentinel lymph node mapping with triple tracer (ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification rate of sentinel lymph node | The ability to identify a sentinel lymph node successfully with different mapping techniques | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of excised sentinel lymph nodes | The effect of mapping technique on the number of excised nodes | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy | 
| False-negative rate of axillary US | False negative rate for SLN surgery in women with normal or axillary US and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100, or vise versa. For abnormal axillary US, false negative rate is calculated similarly. | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy | 
| Morbidity | Lymphedema, shoulder movement pain, or functional deformity after SLNB with different mapping techniques will be assessed by clinicians during follow-up with 3 months periods. The result will be the percentage of patients which suffer from some complications after SLNB or AD. Common morbidity rate after AD is 20%, after SLNB 1-2%. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patent blue, breast, sentinel lymph node, indocyanine green