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Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease (DALIA)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Dotarem
Gadovist
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 MRA-Contrast agent comparison in peripheral disease

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female, aged ≥ 18 years.
  • Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
  • Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.

Exclusion Criteria:

  • Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
  • Patient who had a major cardiovascular event within 30 days prior to the inclusion.
  • Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.

Sites / Locations

  • AKH hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gadovist

Dotarem, interventional

Arm Description

Patient received contrast-enhanced MRA with Gadovist

Patients received contrast-enhanced MRA with Dotarem

Outcomes

Primary Outcome Measures

Intra-patient Accuracy (Percent Agreement), On-site Data
intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.

Secondary Outcome Measures

Intra-patient Accuracy, in Off-site Readings
• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion
Specificity
Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).
Sensitivity
sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).

Full Information

First Posted
December 3, 2009
Last Updated
November 14, 2012
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT01026389
Brief Title
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
Acronym
DALIA
Official Title
Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to 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
MRA-Contrast agent comparison in peripheral disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Gadovist
Arm Type
Active Comparator
Arm Description
Patient received contrast-enhanced MRA with Gadovist
Arm Title
Dotarem, interventional
Arm Type
Experimental
Arm Description
Patients received contrast-enhanced MRA with Dotarem
Intervention Type
Drug
Intervention Name(s)
Dotarem
Other Intervention Name(s)
gadoterate, Gd-Dota
Intervention Description
DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus
Intervention Type
Drug
Intervention Name(s)
Gadovist
Other Intervention Name(s)
gadobutrol
Intervention Description
Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus
Primary Outcome Measure Information:
Title
Intra-patient Accuracy (Percent Agreement), On-site Data
Description
intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.
Time Frame
up to one month
Secondary Outcome Measure Information:
Title
Intra-patient Accuracy, in Off-site Readings
Description
• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion
Time Frame
up to one month
Title
Specificity
Description
Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).
Time Frame
up to one month
Title
Sensitivity
Description
sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).
Time Frame
up to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged ≥ 18 years. Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy. Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations. Exclusion Criteria: Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed. Patient who had a major cardiovascular event within 30 days prior to the inclusion. Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.
Facility Information:
Facility Name
AKH hospital
City
Wien
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease

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