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Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varney Rannells, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00784849
First received: November 3, 2008
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
Results First Received: April 18, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Breast Cancer
Intervention: Drug: Methylene blue

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes

Participant Flow:   Overall Study
    Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue  
STARTED     62  
COMPLETED     62  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes

Baseline Measures
    Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue  
Number of Participants  
[units: participants]
 		  62  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     55  
>=65 years     7  
Gender  
[units: participants]
 		 
Female     62  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     62  



  Outcome Measures
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1.  Primary:   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 ]
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2.  Secondary:   Safety (Allergic Reaction to Blue Dye)   [ Time Frame: intraoperatively up to 6 hours ]
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3.  Secondary:   Superficial Skin Necrosis   [ Time Frame: 2 weeks postoperatively ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes

Serious Adverse Events
    Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue  
Total, serious adverse events    
# participants affected / at risk     0/62 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Eugene Woltering
Organization: LSU Dept of Surgery
phone: 504 464-8500
e-mail: ewolte@lsuhsc.edu


No publications provided


Responsible Party: Varney Rannells, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00784849     History of Changes
Other Study ID Numbers: LSU #6169
Study First Received: November 3, 2008
Results First Received: April 18, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration