Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

Study Overview
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Brief Summary
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The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.

Detailed Description
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This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.

Official Title
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Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Methylene blue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 0,I, II breast cancer Clinical node status N0, N1 No know allergy to iodine, lymphazurin or methylene blue dyes Exclusion Criteria: Patient cannot be pregnant or nursing Prisoners will not be eligible Women under the age of 18 will not be eligible Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>One arm diagnostic | Drug: Methylene blue<br>* 1 mC1<br>* Other names: breast cancer biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) |  | intraoperatively; up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Allergic Reaction to Blue Dye) | number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension | intraoperatively up to 6 hours | 
| Superficial Skin Necrosis | the number of participants who developed post-operative skin necrosis within 2 weeks of surgery | 2 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, diagnostic, lymph nodes