Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)
1 other identifier
interventional
62
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Nov 2004
Typical duration for phase_2 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
June 20, 2012
CompletedJune 20, 2012
May 1, 2012
6.6 years
November 3, 2008
April 18, 2012
May 17, 2012
Conditions
Keywords
Outcome Measures
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)
intraoperatively; up to 6 hours
Secondary Outcomes (2)
Safety (Allergic Reaction to Blue Dye)
intraoperatively up to 6 hours
Superficial Skin Necrosis
2 weeks postoperatively
Study Arms (1)
1
EXPERIMENTALOne arm diagnostic
Interventions
Eligibility Criteria
You may qualify if:
- Stage 0,I, II breast cancer
- Clinical node status N0, N1
- No know allergy to iodine, lymphazurin or methylene blue dyes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Medical Center
Lafayette, Louisiana, 70506, United States
LSU Interim Hospital
New Orleans, Louisiana, 70112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Eugene Woltering
- Organization
- LSU Dept of Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene A Woltering, MD
LSU Health Sciences Center - New Orleans LA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 4, 2008
Study Start
November 1, 2004
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 20, 2012
Results First Posted
June 20, 2012
Record last verified: 2012-05