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

October 5, 2012 updated by: Guerbet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Roissy CDG Cedex, France
        • Guerbet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Image Quality of MRA Images
Time Frame: 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.
MRA examination

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Study Director: Guerbet, Guerbet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

October 5, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGD-44-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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