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

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Other: Contrast-enhanced MRA - Imaging examination

• Registration Number: NCT00955617
• Lead Sponsor: Guerbet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Results First Submitted: 2012-08-08
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-05
• Last Update Submitted: 2012-10-05
• Results First Posted: 2012-11-02
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dotarem / Gadovist	Contrast-enhanced MRA - Imaging examination	Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2
Gadovist / Dotarem	Contrast-enhanced MRA - Imaging examination	Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2

Primary Outcome Measures

Name	Time	Method
Overall Image Quality of MRA Images	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

Name	Time	Method
Diagnostic Confidence	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.
Signal Intensity	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.

Trial Locations

Locations (1)

Guerbet; 🇫🇷 Roissy CDG Cedex, France