NCT00784849

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Methylene blue	1 mC1

Timeline

• Start date: 2004-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-11-04
• Last updated: 2012-06-20
• Results posted: 2012-06-20

Locations

2 sites across 1 country: United States