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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

Tracking Information
First Submitted Date  ICMJE September 17, 2009
First Posted Date  ICMJE September 21, 2009
Results First Submitted Date  ICMJE July 24, 2015
Results First Posted Date  ICMJE May 26, 2016
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ]
For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
  • Blood sampling [ Time Frame: 24 hours ]
  • Tolerance at the injection site [ Time Frame: 24 hours ]
  • Adverse events [ Time Frame: 0 - 58 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Official Title  ICMJE Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Brief Summary The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Detailed Description Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Renal Disease
Intervention  ICMJE
  • Drug: Dotarem
    Each subject will receive one injection of Dotarem 0.2ml/kg
    Other Name: gadoteric acid, gadoterate meglumine
  • Other: Time of Flight
    Each subject will undergo a TOF MRA
Study Arms  ICMJE
  • Experimental: Dotarem
    Each subject will receive one injection of Dotarem 0.2ml/kg.
    Intervention: Drug: Dotarem
  • Time Of Flight
    Each subject will undergo a TOF Magnetic Resonance Angiography
    Intervention: Other: Time of Flight
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 19, 2016)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2009)
220
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, aged more than 18 years
  • Strongly suspected of having renal arterial disease
  • Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination

Exclusion Criteria:

  • Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
  • Contraindication to MRI
  • Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00980681
Other Study ID Numbers  ICMJE DGD-44-047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Guerbet
Original Responsible Party Guerbet, Clinical Development
Current Study Sponsor  ICMJE Guerbet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pierre DESCHE, MD Guerbet
PRS Account Guerbet
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP