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DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases

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ClinicalTrials.gov Identifier: NCT00955617
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : November 2, 2012
Last Update Posted : November 2, 2012
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Description
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Brief Summary:
This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Contrast-enhanced MRA - Imaging examination Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases
Study Start Date : July 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dotarem / Gadovist
Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2
 Other: Contrast-enhanced MRA - Imaging examination
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
Other Names:
  • Dotarem-enhanced MRA
  • Gadovist-enhanced MRA
Experimental: Gadovist / Dotarem
Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2
 Other: Contrast-enhanced MRA - Imaging examination
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
Other Names:
  • Dotarem-enhanced MRA
  • Gadovist-enhanced MRA


Outcome Measures
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Primary Outcome Measures :
  1. Overall Image Quality of MRA Images [ Time Frame: MRA examination ]

    Number of images quoted with excellent and more than adequate quality in each group.

    Image quality will be assessed on a 5-point scale:

    1. Excellent
    2. More than adequate
    3. Adequate
    4. Less than adequate
    5. Non-diagnostic

    Each image is analysed by 4 readers.



Secondary Outcome Measures :
  1. Diagnostic Confidence [ Time Frame: MRA examination ]

    Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.

    Each image is analysed by 4 readers.


  2. Signal Intensity [ Time Frame: MRA examination ]
    Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male, aged ≥ 18 years
  • Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.

Exclusion Criteria:

  • Patients with severely impaired renal function with an eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
  • Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
  • Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955617


Locations
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France
Guerbet
Roissy CDG Cedex, France
Sponsors and Collaborators
Guerbet
Investigators
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Study Director: Guerbet Guerbet
More Information
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00955617    
Other Study ID Numbers: DGD-44-052
First Posted: August 10, 2009    Key Record Dates
Results First Posted: November 2, 2012
Last Update Posted: November 2, 2012
Last Verified: October 2012
Keywords provided by Guerbet:
Dotarem
Gadovist
Peripheral arterial disease
MRA
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases