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Completed

NCT Number: NCT00784849

Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Disease Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center, Lafayette, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylene Blue

Drug

1 mC1

Other names: SNL biopsy, breast cancer biopsy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2008
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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