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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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)

Outcome Time Frame:

intraoperatively; up to 6 hours

Safety Issue:

Yes

Principal Investigator

Eugene A Woltering, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

LSU Health Sciences Center - New Orleans LA

Authority:

United States: Food and Drug Administration

Study ID:

LSU #6169

NCT ID:

NCT00784849

Start Date:

November 2004

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • diagnostic
  • lymph nodes
  • Breast Neoplasms

Name

Location

University Medical CenterLafayette, Louisiana  70506
LSU Interim HospitalNew Orleans, Louisiana  70112