Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Study Overview
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Brief Summary
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We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.

Detailed Description
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Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.

Official Title
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Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Sentinel Node Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer requiring lymph node evaluation Clinically negative lymph nodes in the axilla Willing participation following an informed consent process Exclusion Criteria: Patients with clinically positive lymph nodes Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis) Previous axillary lymphadenectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | Procedure: Sentinel Node Biopsy<br>* Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.<br>* Other names: Lymphazurin Blue Dye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To continue gathering data relating to the sentinel lymph node biopsy procedure. |  | Time of surgery and data analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid. |  | Time of surgery and data analysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Biopsy, Axillary Node Dissection, Intraoperative Injection, Lumpectomy, Mastectomy