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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Contrast-enhanced MRA - Imaging examination
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring Dotarem, Gadovist, Peripheral arterial disease, MRA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guerbet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dotarem / Gadovist

Gadovist / Dotarem

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 6, 2009
Last Updated
October 5, 2012
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT00955617
Brief Title
DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Dotarem, Gadovist, Peripheral arterial disease, MRA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dotarem / Gadovist
Arm Type
Experimental
Arm Description
Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2
Arm Title
Gadovist / Dotarem
Arm Type
Experimental
Arm Description
Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2
Intervention Type
Other
Intervention Name(s)
Contrast-enhanced MRA - Imaging examination
Other Intervention Name(s)
Dotarem-enhanced MRA, Gadovist-enhanced MRA
Intervention Description
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
Primary Outcome Measure Information:
Title
Overall Image Quality of MRA Images
Description
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.
Time Frame
MRA examination
Secondary Outcome Measure Information:
Title
Diagnostic Confidence
Description
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.
Time Frame
MRA examination
Title
Signal Intensity
Description
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.
Time Frame
MRA examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guerbet
Organizational Affiliation
Guerbet
Official's Role
Study Director
Facility Information:
Facility Name
Guerbet
City
Roissy CDG Cedex
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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