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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: NCT00845702
Recruitment Status : Terminated (lack of recruitment.)
First Posted : February 18, 2009
Results First Posted : September 19, 2012
Last Update Posted : May 20, 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 Artery Stenosis
Interventions Drug: Gadoterate meglumine (Dotarem)
Other: Time of Flight Magnetic Resonance Angiography
Enrollment 33
Recruitment Details First Patient First Visit: Apr 2009 Last Patient Last Visit: Feb 2010 Location: Radiology centers
Pre-assignment Details Out of the 33 enrolled patients, one patient did not undergo any of the planned procedures due to an inability to obtain an intravenous access with the initial planned procedure.
Arm/Group Title TOF Followed by Dotarem-enhanced MRA
Hide Arm/Group Description Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
Period Title: TOF MRA
Started 33
Completed 32 [1]
Not Completed 1
[1]
One patient did not perform study MRA procedures.
Period Title: Dotarem MRA
Started 32
Completed 32
Not Completed 0
Arm/Group Title TOF and Dotarem Enhanced MRA
Hide Arm/Group Description Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
Baseline measures were recorded for all 33 patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  51.5%
>=65 years
16
  48.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
62  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
16
  48.5%
Male
17
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Percent of Non Assessable Renal Artery Segments
Hide Description For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
Time Frame 1 to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study has been prematurely terminated, and the planned analyses were not done
Arm/Group Title Dotarem MRA Time Of Flight MRA
Hide Arm/Group Description:
Each subject will receive one injection of Dotarem 0.2 ml/kg.
Each subject will undergo a TOF MRA
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dotarem Magnetic Resonance Angiography Time Of Flight MRA
Hide Arm/Group Description Each subject will receive one injection of Dotarem 0.2 ml/kg. Subjects undergo a TOF MRA
All-Cause Mortality
Dotarem Magnetic Resonance Angiography Time Of Flight MRA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dotarem Magnetic Resonance Angiography Time Of Flight MRA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/32 (3.13%)      0/32 (0.00%)    
Psychiatric disorders     
Mental status changed *  1/32 (3.13%)  1 0/32 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Dotarem Magnetic Resonance Angiography Time Of Flight MRA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/32 (18.75%)      0/32 (0.00%)    
General disorders     
General disorders *  2/32 (6.25%)  2 0/32 (0.00%)  0
Infections and infestations     
Infection *  1/32 (3.13%)  1 0/32 (0.00%)  0
Investigations     
Investigation *  3/32 (9.38%)  3 0/32 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
The study was not completed due to poor enrollment. The statistical analysis was not performed.
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: NCT00845702    
Other Study ID Numbers: DGD-44-046
First Submitted: February 16, 2009
First Posted: February 18, 2009
Results First Submitted: September 22, 2011
Results First Posted: September 19, 2012
Last Update Posted: May 20, 2016