Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106040
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : June 3, 2013
Last Update Posted : June 17, 2013
Information provided by (Responsible Party):
Navidea Biopharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Breast Cancer
Intervention: Drug: Lymphoseek

  Participant Flow

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
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 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 163 participants who enrolled in the trial, 153 were administered the study agent, Lymphoseek, and therefore this participant number is used for the baseline analysis.

Reporting Groups
Lymphoseek Enrolled patients who were administered any injection of Lymphoseek.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   101 
>=65 years   52 
[Units: Years]
Mean (Standard Deviation)
 59.3  (12.4) 
[Units: Participants]
Female   104 
Male   49 
Region of Enrollment 
[Units: Participants]
United States   153 

  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

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