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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784849
Recruitment Status : Completed
First Posted : November 4, 2008
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Information provided by (Responsible Party):
Varney Rannells, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Methylene blue Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)
Study Start Date : November 2004
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
One arm diagnostic
Drug: Methylene blue
1 mC1
Other Names:
  • SNL biopsy
  • breast cancer biopsy

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Superficial Skin Necrosis [ Time Frame: 2 weeks postoperatively ]
    the number of participants who developed post-operative skin necrosis within 2 weeks of surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784849

United States, Louisiana
University Medical Center
Lafayette, Louisiana, United States, 70506
LSU Interim Hospital
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Eugene A Woltering, MD LSU Health Sciences Center - New Orleans LA

Responsible Party: Varney Rannells, Research Coordinator, Louisiana State University Health Sciences Center in New Orleans Identifier: NCT00784849     History of Changes
Other Study ID Numbers: LSU #6169
First Posted: November 4, 2008    Key Record Dates
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012
Last Verified: May 2012

Keywords provided by Varney Rannells, Louisiana State University Health Sciences Center in New Orleans:
Breast cancer
lymph nodes

Additional relevant MeSH terms:
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action