Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
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ClinicalTrials.gov Identifier: NCT00784849
: November 4, 2008
Results First Posted
: June 20, 2012
Last Update Posted
: June 20, 2012
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Varney Rannells, Louisiana State University Health Sciences Center in New Orleans
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.
Condition or disease
Drug: Methylene blue
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.
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) [ Time Frame: intraoperatively; up to 6 hours ]
Secondary Outcome Measures
Safety (Allergic Reaction to Blue Dye) [ Time Frame: intraoperatively up to 6 hours ]
number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension
Superficial Skin Necrosis [ Time Frame: 2 weeks postoperatively ]
the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Stage 0,I, II breast cancer
Clinical node status N0, N1
No know allergy to iodine, lymphazurin or methylene blue dyes
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