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
No text entered.

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
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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
  Description
Lymphoseek Enrolled patients who were administered any injection of Lymphoseek.

Baseline Measures
    Lymphoseek  
Number of Participants  
[units: participants]
  153  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     101  
>=65 years     52  
Age  
[units: years]
Mean ± Standard Deviation
  59.3  ± 12.4  
Gender  
[units: participants]
 
Female     104  
Male     49  
Region of Enrollment  
[units: participants]
 
United States     153  



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

Measure Type Primary
Measure Title Concordance of Blue Dye and Lymphoseek
Measure Description The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
Time Frame Surgery after injections of Lymphoseek and blue dye  
Safety Issue No  

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.
All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.

Reporting Groups
  Description
Intent-To-Treat Participants received 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.

Measured Values
    Intent-To-Treat  
Number of Participants Analyzed  
[units: participants]
  133  
Number of Lymph Nodes Analyzed  
[units: Lymph Nodes]
  229  
Concordance of Blue Dye and Lymphoseek  
[units: Proportion of Lymph Nodes]
Number ( 95% Confidence Interval )
  1.0000  
  ( 0.9840 to 1.0000 )  

No statistical analysis provided for Concordance of Blue Dye and Lymphoseek



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

Measure Type Secondary
Measure Title Reverse Concordance of Blue Dye and Lymphoseek
Measure Description The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.
Time Frame Surgery after injections of Lymphoseek and blue dye  
Safety Issue No  

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.
All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.

Reporting Groups
  Description
Reverse Intent-To-Treat Participants received 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.

Measured Values
    Reverse Intent-To-Treat  
Number of Participants Analyzed  
[units: participants]
  152  
Number of Lymph Nodes Analyzed  
[units: Lymph Nodes]
  378  
Reverse Concordance of Blue Dye and Lymphoseek  
[units: Proportion of Lymph Nodes]
Number ( 95% Confidence Interval )
  0.6058  
  ( 0.5546 to 0.6554 )  

No statistical analysis provided for Reverse Concordance of Blue Dye and Lymphoseek




  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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Frederick Cope
Organization: Navidea Biopharmaceuticals
phone: 614-793-7500 ext 140
e-mail: fcope@navidea.com


Publications of Results:

Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01106040     History of Changes
Other Study ID Numbers: NEO3-09
Study First Received: April 14, 2010
Results First Received: April 13, 2013
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration