We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 16, 2009
First Posted Date  ICMJE February 18, 2009
Results First Submitted Date  ICMJE September 22, 2011
Results First Posted Date  ICMJE September 19, 2012
Last Update Posted Date May 20, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ]
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 Artery Stenosis
Intervention  ICMJE
  • Drug: Gadoterate meglumine (Dotarem)
    Each subject will receive one injection of Dotarem 0.2 ml/kg
  • Other: Time of Flight Magnetic Resonance Angiography
    Each subject will undergo a TOF MRA
Study Arms  ICMJE
  • Experimental: Dotarem
    Each subject will receive one injection of Dotarem 0.2 ml/kg.
    Intervention: Drug: Gadoterate meglumine (Dotarem)
  • Time Of Flight Magnetic Resonance Angiography
    Each subject undergo a TOF MRA
    Intervention: Other: Time of Flight Magnetic Resonance Angiography
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: September 18, 2012)
33
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 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 France
 
Administrative Information
NCT Number  ICMJE NCT00845702
Other Study ID Numbers  ICMJE DGD-44-046
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 Not Provided
Current Study Sponsor  ICMJE Guerbet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
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