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Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients (IJBMNZrT003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01420146
First received: August 8, 2011
Last updated: March 7, 2017
Last verified: January 2015
Results First Received: March 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Diagnostic
Conditions: Breast Neoplasms
Secondary
HER2 Positive Carcinoma of Breast
Intervention: Drug: Zr89-trastuzumab

  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
Zr89-trastuzumab PET/CT Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm

Participant Flow:   Overall Study
    Zr89-trastuzumab PET/CT
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Zr89-trastuzumab PET/CT Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm

Baseline Measures
   Zr89-trastuzumab PET/CT 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15  75.0% 
>=65 years      5  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
Belgium   20 


  Outcome Measures

1.  Primary:   Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings   [ Time Frame: 4 years ]

2.  Secondary:   Time Activity Curve   [ Time Frame: blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   HER2 Extracellular Domain   [ Time Frame: within 60 min before tracer injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Géraldine Gebhart
Organization: Institut Jules Bordet
phone: 025413095 ext +32
e-mail: geraldine.gebhart@bordet.be



Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01420146     History of Changes
Other Study ID Numbers: IJBMNZrT003
Study First Received: August 8, 2011
Results First Received: March 7, 2017
Last Updated: March 7, 2017