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SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00522951
First received: August 29, 2007
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
Results First Received: July 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Diagnostic
Condition: Brain Metastases
Interventions: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Drug: ProHance

  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
A total of 175 participants were enrolled into the study. 10 were withdrawn from the study before entering Study Period 1. Safety Analysis Set included 164 participants; gadobutrol=161, ProHance=162. Per Protocol Set (PPS) included 151 participants.

Reporting Groups
  Description
Gadobutrol Then Gadoteridol Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
Gadoteridol Then Gadobutrol Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2

Participant Flow for 3 periods

 Period 1:   Period 1
    Gadobutrol Then Gadoteridol     Gadoteridol Then Gadobutrol  
STARTED     86     79  
Received Treatment     86     78  
COMPLETED     86     78  
NOT COMPLETED     0     1  
body motion                 0                 1  

Period 2:   Washout Period
    Gadobutrol Then Gadoteridol     Gadoteridol Then Gadobutrol  
STARTED     86     78  
COMPLETED     86     76  
NOT COMPLETED     0     2  
Adverse Event                 0                 1  
Death                 0                 1  

Period 3:   Period 2
    Gadobutrol Then Gadoteridol     Gadoteridol Then Gadobutrol  
STARTED     86     76  
Subjects Received Treatment     84     75  
COMPLETED     84     75  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 0  
residual contrast medium                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population includes all participants received treatment

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  164  
Age  
[units: years]
Mean ± Standard Deviation 		  61.7  ± 11.8  
Gender  
[units: participants]
 		 
Female     74  
Male     90  
Height  
[units: cm]
Mean ± Standard Deviation 		  160.9  ± 8.7  
Body weight  
[units: kg]
Mean ± Standard Deviation 		  56.7  ± 12.2  
Primary focus  
[units: participants]
 		 
Lung cancer     123  
Breast cancer     20  
Others     21  



  Outcome Measures
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1.  Primary:   Number of Lesions Detected by Blinded Readers (BR) and Investigator   [ Time Frame: one day ]
  Show Outcome Measure 1

2.  Secondary:   Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader   [ Time Frame: one day ]
  Show Outcome Measure 2

3.  Secondary:   Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator   [ Time Frame: one day ]
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4.  Secondary:   Score of Visibility Assessment - Border Delineation by Blinded Reader   [ Time Frame: one day ]
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5.  Secondary:   Score of Visibility Assessment - Border Delineation by Investigator   [ Time Frame: one day ]
  Show Outcome Measure 5

6.  Secondary:   Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)   [ Time Frame: one day ]
  Show Outcome Measure 6

7.  Secondary:   Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator   [ Time Frame: one day ]
  Show Outcome Measure 7

8.  Secondary:   Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE   [ Time Frame: one day ]
  Show Outcome Measure 8

9.  Secondary:   Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator   [ Time Frame: one day ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE   [ Time Frame: one day ]
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11.  Secondary:   Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator   [ Time Frame: one day ]
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12.  Secondary:   Number of Participants With Reasons for Performance in SRS Planning by TPE   [ Time Frame: one day ]
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13.  Secondary:   Number of Participants With Reasons for Performance in SRS Planning by Investigator   [ Time Frame: one day ]
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14.  Secondary:   Lesion Size Evaluated by Independent Radiologist   [ Time Frame: one day ]
  Show Outcome Measure 14

15.  Secondary:   Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist   [ Time Frame: one day ]
  Show Outcome Measure 15

16.  Secondary:   Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions   [ Time Frame: one day ]
  Show Outcome Measure 16


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


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
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Therapeutic Area Head, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT00522951     History of Changes
Other Study ID Numbers: 91569, 310864
Study First Received: August 29, 2007
Results First Received: July 5, 2011
Last Updated: October 31, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare