Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01010932
First received: November 9, 2009
Last updated: August 25, 2015
Last verified: August 2015
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Cerebral Arterial Diseases
Interventions: Drug: Dotarem
Other: TOF MRA

  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
First patient first visit: 21 Sep 2009. Last patient last visit: 18 Nov 2010. Location: radiology departments

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 222 patients fulfilling the eligibility criteria were enrolled, of which 200 patients received Dotarem and completed the study. Twenty-two patients did not receive Dotarem and were discontinued prematurely.

Reporting Groups
  Description
TOF MRA Followed by Dotarem-enhanced MRA

Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.

Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.


Participant Flow:   Overall Study
    TOF MRA Followed by Dotarem-enhanced MRA  
STARTED     222  
COMPLETED     200  
NOT COMPLETED     22  



  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
TOF MRA Followed by Dotarem-enhanced MRA

Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.

Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.


Baseline Measures
    TOF MRA Followed by Dotarem-enhanced MRA  
Number of Participants  
[units: participants]
  222  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     108  
>=65 years     114  
Age  
[units: years]
Mean (Standard Deviation)
  64.8  (11.9)  
Gender  
[units: participants]
 
Female     105  
Male     117  
Region of Enrollment  
[units: participants]
 
United States     81  
Colombia     35  
Argentina     48  
Mexico     18  
Korea, Republic of     39  
Chile     1  



  Outcome Measures
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1.  Primary:   Technical Failure Rate   [ Time Frame: 2 - 28 days ]

2.  Primary:   Sensitivity   [ Time Frame: 2-42 days ]

3.  Primary:   Specificity   [ Time Frame: 2 - 42 days ]

4.  Secondary:   Sensitivity and Specificity at Patient Level and at Segment Level Excluding Non-assessable Segments   [ Time Frame: 2-42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Positive and Negative Predictive Values of Dotarem-enhanced MRA and TOF MRA at Patient Level and at Segment Level   [ Time Frame: 2 - 42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Inter and Intra-readers Agreement at the Segment Level   [ Time Frame: 2 -42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Rates of the Different Reasons for Technical Failure for Both MRA Procedures   [ Time Frame: 2 -42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Quality of Images of Both MRA Procedures   [ Time Frame: 2 - 42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Level of Diagnostic Confidence for Both MRA Procedures   [ Time Frame: 2 -42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Size of Stenoses for All Imaging Procedures (MRA and Gold Standard)   [ Time Frame: 2 -42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Duration of Examination   [ Time Frame: 2-42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Rates of the Recommended Clinical Management   [ Time Frame: 2 -42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Adverse Events   [ Time Frame: 0 - 42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

14.  Secondary:   Blood Sampling   [ Time Frame: 24 hours after Dotarem injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

15.  Secondary:   Tolerance at the Injection Site   [ Time Frame: 24 hours after Dotarem injection ]
Results not yet reported.   Anticipated Reporting 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
No text entered.


  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: Dr Pierre Desché, MD - VP Head of Development, Medical and Regulatory Affairs
Organization: Guerbet
phone: +33 1 45 91 50 00
e-mail: pierre.desche@guerbet-group.com


No publications provided


Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01010932     History of Changes
Other Study ID Numbers: DGD-44-048
Study First Received: November 9, 2009
Results First Received: July 29, 2015
Last Updated: August 25, 2015
Health Authority: United States: Food and Drug Administration