Text Size

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:
NCT00845702
First received: February 16, 2009
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.


Condition Intervention Phase
Renal Artery Stenosis
 Drug: Gadoterate meglumine (Dotarem)
Other: Time of Flight Magnetic Resonance Angiography
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ] [ Designated as safety issue: No ]
    For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared


Enrollment: 33
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2 ml/kg.
 Drug: Gadoterate meglumine (Dotarem)
Each subject will receive one injection of Dotarem 0.2 ml/kg
Time Of Flight Magnetic Resonance Angiography
Each subject undergo a TOF MRA
 Other: Time of Flight Magnetic Resonance Angiography
Each subject will undergo a TOF MRA

Detailed Description:

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845702

Locations
United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00845702     History of Changes
Other Study ID Numbers: DGD-44-046
Study First Received: February 16, 2009
Results First Received: September 22, 2011
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Guerbet:
Renal artery stenosis
Contrast agent
MRA

Additional relevant MeSH terms:
Constriction, Pathologic
Renal Artery Obstruction
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013