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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Methylene blue

• Registration Number: NCT00784849
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-04-18
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-17
• Last Update Submitted: 2012-05-17
• Results First Posted: 2012-06-20
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Methylene blue	One arm diagnostic

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

University Medical Center; 🇺🇸 Lafayette, Louisiana, United States

LSU Interim Hospital; 🇺🇸 New Orleans, Louisiana, United States