Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01106040
First received: April 14, 2010
Last updated: June 6, 2013
Last verified: June 2013
Results First Received: April 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Breast Cancer
Melanoma
Intervention: Drug: Lymphoseek

  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
Lymphoseek, Lymphatic Mapping, Injection Melanoma and breast cancer patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.

Participant Flow:   Overall Study
    Lymphoseek, Lymphatic Mapping, Injection  
STARTED     163  
COMPLETED     152  
NOT COMPLETED     11  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Concordance of Blue Dye and Lymphoseek   [ Time Frame: Surgery after injections of Lymphoseek and blue dye ]

2.  Secondary:   Reverse Concordance of Blue Dye and Lymphoseek   [ Time Frame: Surgery after injections of Lymphoseek and blue dye ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information