Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

This study has been terminated.
(Lack of recruitment.)
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00980681
First received: September 17, 2009
Last updated: April 19, 2016
Last verified: April 2016
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Renal Disease
Interventions: Drug: Dotarem
Other: Time of Flight

  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
The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study

Reporting Groups
  Description
TOF Followed by Dotarem-enhanced MRA Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).

Participant Flow for 2 periods

Period 1:   TOF MRA
    TOF Followed by Dotarem-enhanced MRA  
STARTED     10 [1]
COMPLETED     10  
NOT COMPLETED     0  
[1] Out of the 13 enrolled patients, three did not receive treatment

Period 2:   Dotarem MRA
    TOF Followed by Dotarem-enhanced MRA  
STARTED     10 [1]
COMPLETED     10  
NOT COMPLETED     0  
[1] Out of the 13 enrolled patients, three did not receive treatment



  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 Followed by Dotarem-enhanced MRA Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).

Baseline Measures
    TOF Followed by Dotarem-enhanced MRA  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     6  
Age  
[units: years]
Mean (Standard Deviation)
  59  (16)  
Gender  
[units: participants]
 
Female     9  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     7  
Canada     6  



  Outcome Measures

1.  Primary:   Percent of Non Assessable Renal Artery Segments   [ Time Frame: 1 to 7 days ]


  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
The study was not completed due to poor enrolment. The statistical analysis was not perfomed.


  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.


Results Point of Contact:  
Name/Title: Pierre Desche, MD, Head of Clinical and Regulatory Affairs
Organization: Guerbet
phone: +33 1 45 91 50 00
e-mail: pierre.desche@guerbet-group.com



Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00980681     History of Changes
Other Study ID Numbers: DGD-44-047
Study First Received: September 17, 2009
Results First Received: July 24, 2015
Last Updated: April 19, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada