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

May 17, 2012 updated by: Varney Rannells, Louisiana State University Health Sciences Center in New Orleans

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • University Medical Center
      • New Orleans, Louisiana, United States, 70112
        • LSU Interim Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
intraoperatively; up to 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperatively up to 6 hours
Superficial Skin Necrosis
Time Frame: 2 weeks postoperatively
the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
2 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Investigators

  • Principal Investigator: Eugene A Woltering, MD, LSU Health Sciences Center - New Orleans LA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSU #6169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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