- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784849
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
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
-
-
Louisiana
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Lafayette, Louisiana, United States, 70506
- University Medical Center
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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
|
1 mC1
Other Names:
|
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.
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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Seoul National University HospitalUnknown
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University of Nove de JulhoEnrolling by invitation
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University of OxfordOxford University Hospitals NHS TrustUnknown
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National Cancer Institute, EgyptRecruiting