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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Contrast-enhanced MRA - Imaging examination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotarem / Gadovist<br>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<br>* Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)<br>* Other names: Gadovist-enhanced MRA;|
| Experimental: Gadovist / Dotarem<br>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<br>* Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)<br>* Other names: Gadovist-enhanced MRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Excellent More than adequate Adequate Less than adequate Non-diagnostic Each image is analysed by 4 readers. | MRA examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Confidence | 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. | MRA examination | 
| Signal Intensity | 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. | MRA examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dotarem, Gadovist, Peripheral arterial disease, MRA