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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00955617
First received: August 6, 2009
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
 Other: Contrast-enhanced MRA - Imaging examination
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Overall Image Quality of MRA Images [ Time Frame: MRA examination ] [ Designated as safety issue: No ]

    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:
  • Diagnostic Confidence [ Time Frame: MRA examination ] [ Designated as safety issue: No ]

    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.


  • Signal Intensity [ Time Frame: MRA examination ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955617

Locations
France
Guerbet
Roissy CDG Cedex, France
Sponsors and Collaborators
Guerbet
Investigators
Study Director: Guerbet Guerbet
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00955617     History of Changes
Other Study ID Numbers: DGD-44-052
Study First Received: August 6, 2009
Results First Received: August 8, 2012
Last Updated: October 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Guerbet:
Dotarem
Gadovist
Peripheral arterial disease
MRA

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013