Status:
COMPLETED
Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
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 radioact...
Eligibility Criteria
Inclusion
- Stage 0,I, II breast cancer
- Clinical node status N0, N1
- No know allergy to iodine, lymphazurin or methylene blue dyes
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00784849
Start Date
November 1 2004
End Date
June 1 2011
Last Update
June 20 2012
Active Locations (2)
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1
University Medical Center
Lafayette, Louisiana, United States, 70506
2
LSU Interim Hospital
New Orleans, Louisiana, United States, 70112