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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00980681
Recruitment Status : Terminated (Lack of recruitment.)
First Posted : September 21, 2009
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Renal Disease
Interventions Drug: Dotarem
Other: Time of Flight
Enrollment 13
Recruitment Details The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.
Pre-assignment Details Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study
Arm/Group Title TOF Followed by Dotarem-enhanced MRA
Hide Arm/Group Description 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).
Period Title: TOF MRA
Started 10 [1]
Completed 10
Not Completed 0
[1]
Out of the 13 enrolled patients, three did not receive treatment
Period Title: Dotarem MRA
Started 10 [1]
Completed 10
Not Completed 0
[1]
Out of the 13 enrolled patients, three did not receive treatment
Arm/Group Title TOF Followed by Dotarem-enhanced MRA
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  53.8%
>=65 years
6
  46.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
59  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
9
  69.2%
Male
4
  30.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
United States 7
Canada 6
1.Primary Outcome
Title Percent of Non Assessable Renal Artery Segments
Hide Description For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Time Frame 1 to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dotarem-enhanced MRA Time-Of-Flight MRA
Hide Arm/Group Description:
Patients benefiting from an MRA after administration with Dotarem
Patients benefiting from an MRA with no injection of contrast medium
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: percentage of non-assessable segments
25 20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dotarem Time Of Flight
Hide Arm/Group Description

Each subject will receive one injection of Dotarem 0.2ml/kg.

Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg

Each subject will undergo a TOF Magnetic Resonance Angiography

Time of Flight: Each subject will undergo a TOF MRA

All-Cause Mortality
Dotarem Time Of Flight
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dotarem Time Of Flight
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dotarem Time Of Flight
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/10 (40.00%)      0/10 (0.00%)    
Gastrointestinal disorders     
Abdominal pain  1/10 (10.00%)  1 0/10 (0.00%)  0
Diarrhea  1/10 (10.00%)  1 0/10 (0.00%)  0
General disorders     
Injection site pain  2/10 (20.00%)  2 0/10 (0.00%)  0
Injection site inflammation  1/10 (10.00%)  1 0/10 (0.00%)  0
The study was not completed due to poor enrolment. The statistical analysis was not perfomed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pierre Desche, MD, Head of Clinical and Regulatory Affairs
Organization: Guerbet
Phone: +33 1 45 91 50 00
EMail: pierre.desche@guerbet-group.com
Layout table for additonal information
Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00980681    
Other Study ID Numbers: DGD-44-047
First Submitted: September 17, 2009
First Posted: September 21, 2009
Results First Submitted: July 24, 2015
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016