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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varney Rannells, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00784849
First received: November 3, 2008
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Methylene blue
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety (Allergic Reaction to Blue Dye) [ Time Frame: intraoperatively up to 6 hours ] [ Designated as safety issue: Yes ]
    number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension

  • Superficial Skin Necrosis [ Time Frame: 2 weeks postoperatively ] [ Designated as safety issue: Yes ]
    the number of participants who developed post-operative skin necrosis within 2 weeks of surgery


Enrollment: 62
Study Start Date: November 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
One arm diagnostic
Drug: Methylene blue
1 mC1
Other Names:
  • SNL biopsy
  • breast cancer biopsy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784849

Locations
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
Investigators
Principal Investigator: Eugene A Woltering, MD LSU Health Sciences Center - New Orleans LA
  More Information

No publications provided

Responsible Party: Varney Rannells, Research Coordinator, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00784849     History of Changes
Other Study ID Numbers: LSU #6169
Study First Received: November 3, 2008
Results First Received: April 18, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014