DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
November 2, 2012
CompletedNovember 2, 2012
October 1, 2012
11 months
August 6, 2009
August 8, 2012
October 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Image Quality of MRA Images
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.
MRA examination
Secondary Outcomes (2)
Diagnostic Confidence
MRA examination
Signal Intensity
MRA examination
Study Arms (2)
Dotarem / Gadovist
EXPERIMENTALContrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2
Gadovist / Dotarem
EXPERIMENTALContrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2
Interventions
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
Eligibility Criteria
You may qualify if:
- Female or male, aged ≥ 18 years
- Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guerbetlead
Study Sites (1)
Guerbet
Roissy CDG, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitation of the study: descriptive study
Results Point of Contact
- Title
- Emilie Huchet
- Organization
- Guerbet
Study Officials
- STUDY DIRECTOR
Guerbet
Guerbet
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 10, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2010
Study Completion
October 1, 2010
Last Updated
November 2, 2012
Results First Posted
November 2, 2012
Record last verified: 2012-10