Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilex
ClinicalTrials.gov Identifier:
NCT00606632
First received: January 21, 2008
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: June 7, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Renal Cell Carcinoma
Kidney Cancer
Interventions: Drug: 124-Iodine-cG250 (124I-cG250)
Procedure: CT

  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
226 subjects were enrolled at 14 study sites in the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PET/CT Versus CT PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.

Participant Flow:   Overall Study
    PET/CT Versus CT  
STARTED     226  
COMPLETED     204  
NOT COMPLETED     22  
Withdrawal by Subject                 13  
Miscellaneous reasons                 9  



  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.
No text entered.

Reporting Groups
  Description
PET/CT Versus CT All subjects were scheduled to receive a PET/CT and a diagnostic CT

Baseline Measures
    PET/CT Versus CT  
Number of Participants  
[units: participants]
  226  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     167  
>=65 years     59  
Age  
[units: years]
Mean ± Standard Deviation
  56.1  ± 12.01  
Gender  
[units: participants]
 
Female     84  
Male     142  
Region of Enrollment  
[units: participants]
 
United States     226  



  Outcome Measures

1.  Primary:   Sensitivity - Proportion of Participant Determinded to Have Clear Cell Renal Carcinoma (ccRCC) by PET/CT.   [ Time Frame: 6 months ]

2.  Primary:   Reading of Diagnostic CT Imaging in Renal Masses to Decide on the Presence or Absence of ccRCC.   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Safety Evaluation of 124I -cG250 in Patients With Renal Masses   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roman Bartz
Organization: Wilex AG
phone: +49 89413138 ext 52
e-mail: roman.bartz@wilex.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Wilex
ClinicalTrials.gov Identifier: NCT00606632     History of Changes
Other Study ID Numbers: WX/20-001
Study First Received: January 21, 2008
Results First Received: June 7, 2011
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration