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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955617
• Other study ID #: DGD-44-052
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2009
• Last updated: October 5, 2012
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2012
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Contrast-enhanced MRA - Imaging examination
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)

Locations

Country	Name	City	State
France	Guerbet	Roissy CDG Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No