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

• ClinicalTrials.gov Identifier: NCT01026389
• Recruitment Status: Completed
• First Posted: December 4, 2009
• Results First Posted: December 11, 2012
• Last Update Posted: December 11, 2012
• Sponsor: Guerbet
• Information provided by (Responsible Party): Guerbet

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Drug: Dotarem; Drug: Gadovist	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 189 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• 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 Start Date: October 2009
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Gadovist; Patient received contrast-enhanced MRA with Gadovist	Drug: Gadovist; Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus; Other Name: gadobutrol
Experimental: Dotarem, interventional; Patients received contrast-enhanced MRA with Dotarem	Drug: Dotarem; DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus; Other Names: gadoterate; Gd-Dota

Outcome Measures

Primary Outcome Measures :

1. Intra-patient Accuracy (Percent Agreement), On-site Data [ Time Frame: up to one month ]
   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 :

1. Intra-patient Accuracy, in Off-site Readings [ Time Frame: up to one month ]
   • 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
2. Specificity [ Time Frame: up to one month ]
   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).
3. Sensitivity [ Time Frame: up to one month ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Austria

AKH hospital

Wien, Austria

Sponsors and Collaborators

Guerbet

More Information

• Responsible Party: Guerbet
• ClinicalTrials.gov Identifier: NCT01026389
• Other Study ID Numbers: DGD 44-045
• First Posted: December 4, 2009
• Results First Posted: December 11, 2012
• Last Update Posted: December 11, 2012
• Last Verified: November 2012

Keywords provided by Guerbet:

MRA-Contrast agent comparison in peripheral disease

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action