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

• Sponsor: Guerbet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01026389
• Collaborator: (none)
• Enrollment: 189
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 7

Study Details

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
• 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: Oct 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jan 1, 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 Names: 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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	AKH hospital	Wien		Austria

Sponsors and Collaborators

• Guerbet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guerbet
• ClinicalTrials.gov Identifier: NCT01026389
• Other Study ID Numbers: DGD 44-045
• First Posted: Dec 4, 2009
• Last Update Posted: Dec 11, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Guerbet: MRA-Contrast agent comparison in peripheral disease
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Study Results

Participant Flow

Recruitment Details	Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.
Pre-assignment Detail	3 patients were not randomized: 2 patients because of technical issue and one patient because of sponsor decision (inclusion period finished/ number of evaluable patients achieved)

Arm/Group Title	Gadovist	Dotarem
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist	Patients received contrast-enhanced MRA with Dotarem
Period Title: Overall Study
STARTED	93	93
COMPLETED	88	88
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Gadovist	Dotarem, Interventional	Total
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist	Patients received contrast-enhanced MRA with Dotarem	Total of all reporting groups
Overall Participants	93	93	186
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	48 51.6%	48 51.6%	96 51.6%
>=65 years	45 48.4%	45 48.4%	90 48.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.5 (10.2)	66.8 (10.6)	66.7 (10.4)
Sex: Female, Male (Count of Participants)
Female	21 22.6%	18 19.4%	39 21%
Male	72 77.4%	75 80.6%	147 79%
Region of Enrollment (participants) [Number]
Austria	19 20.4%	18 19.4%	37 19.9%
France	16 17.2%	20 21.5%	36 19.4%
Germany	7 7.5%	7 7.5%	14 7.5%
Italy	16 17.2%	16 17.2%	32 17.2%
Spain	35 37.6%	32 34.4%	67 36%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Gadovist	Dotarem, Interventional
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist	Patients received contrast-enhanced MRA with Dotarem
Measure Participants	87	86
Mean (Standard Deviation) [percentage of agreement]	77.1 (19.6)	80.6 (16.1)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice. Per protocol population

Arm/Group Title	Gadovist	Dotarem, Interventional
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist	Patients received contrast-enhanced MRA with Dotarem
Measure Participants	78	76
Measure images	156	152
Mean (Standard Deviation) [percentage of agreement]	75.1 (15.3)	73.9 (16.7)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Gadovist	Dotarem, Interventional
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist	Patients received contrast-enhanced MRA with Dotarem
Measure Participants	79	77
Measure Negative segment with gold standard	819	824
Number [negative segments in MRA]	756	763

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Gadovist	Dotarem, Interventional
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist	Patients received contrast-enhanced MRA with Dotarem
Measure Participants	79	77
Measure positive segment with gold standard	238	264
Number [positive segment with MRA]	168	191

Adverse Events

Time Frame	15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA
Arm/Group Title	Gadovist		Dotarem, Interventional
Arm/Group Description	Patient received contrast-enhanced MRA with Gadovist		Patients received contrast-enhanced MRA with Dotarem
All Cause Mortality
	Gadovist		Dotarem, Interventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Gadovist		Dotarem, Interventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		1/93 (1.1%)
Cardiac disorders
Acute coronary syndrome	0/93 (0%)	0	1/93 (1.1%)	1
Nervous system disorders
carotid stenosis	0/93 (0%)	0	1/93 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Gadovist		Dotarem, Interventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/92 (2.2%)		2/92 (2.2%)
General disorders
contrast extravasation	1/92 (1.1%)	1	0/92 (0%)	0
Infections and infestations
Folliculis	0/92 (0%)	0	1/92 (1.1%)	1
Nervous system disorders
burning	0/92 (0%)	0	1/92 (1.1%)	1
Vascular disorders
heat sensation in the face	1/92 (1.1%)	1	0/92 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.