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

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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:
Information provided by (Responsible Party):
Guerbet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Peripheral Arterial Disease
Interventions Drug: Dotarem
Drug: Gadovist
Enrollment 189
Recruitment Details Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Withdrawal by Subject             1             3
change of treatment, patient moved             4             2
Arm/Group Title Gadovist Dotarem, Interventional Total
Hide Arm/Group Description Patient received contrast-enhanced MRA with Gadovist Patients received contrast-enhanced MRA with Dotarem Total of all reporting groups
Overall Number of Baseline Participants 93 93 186
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 93 participants 186 participants
<=18 years
0
   0.0%
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 Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 93 participants 186 participants
66.5  (10.2) 66.8  (10.6) 66.7  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 93 participants 186 participants
Female
21
  22.6%
18
  19.4%
39
  21.0%
Male
72
  77.4%
75
  80.6%
147
  79.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 93 participants 186 participants
Austria 19 18 37
France 16 20 36
Germany 7 7 14
Italy 16 16 32
Spain 35 32 67
1.Primary Outcome
Title Intra-patient Accuracy (Percent Agreement), On-site Data
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Gadovist Dotarem, Interventional
Hide Arm/Group Description:
Patient received contrast-enhanced MRA with Gadovist
Patients received contrast-enhanced MRA with Dotarem
Overall Number of Participants Analyzed 87 86
Mean (Standard Deviation)
Unit of Measure: percentage of agreement
77.1  (19.6) 80.6  (16.1)
2.Secondary Outcome
Title Intra-patient Accuracy, in Off-site Readings
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Patient received contrast-enhanced MRA with Gadovist
Patients received contrast-enhanced MRA with Dotarem
Overall Number of Participants Analyzed 78 76
Overall Number of Units Analyzed
Type of Units Analyzed: Images
156 152
Mean (Standard Deviation)
Unit of Measure: percentage of agreement
75.1  (15.3) 73.9  (16.7)
3.Secondary Outcome
Title Specificity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol population
Arm/Group Title Gadovist Dotarem, Interventional
Hide Arm/Group Description:
Patient received contrast-enhanced MRA with Gadovist
Patients received contrast-enhanced MRA with Dotarem
Overall Number of Participants Analyzed 79 77
Overall Number of Units Analyzed
Type of Units Analyzed: Negative segment with gold standard
819 824
Measure Type: Number
Unit of Measure: negative segments in MRA
756 763
4.Secondary Outcome
Title Sensitivity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Gadovist Dotarem, Interventional
Hide Arm/Group Description:
Patient received contrast-enhanced MRA with Gadovist
Patients received contrast-enhanced MRA with Dotarem
Overall Number of Participants Analyzed 79 77
Overall Number of Units Analyzed
Type of Units Analyzed: Positive segment with gold standard
238 264
Measure Type: Number
Unit of Measure: positive segment with MRA
168 191
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadovist Dotarem, Interventional
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Gadovist Dotarem, Interventional
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/93 (0.00%)      1/93 (1.08%)    
Cardiac disorders     
Acute coronary syndrome  1 [1]  0/93 (0.00%)  0 1/93 (1.08%)  1
Nervous system disorders     
carotid stenosis  1 [1]  0/93 (0.00%)  0 1/93 (1.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Not related, occured prior to administration of study treatment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.01%
Gadovist Dotarem, Interventional
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/92 (2.17%)      2/92 (2.17%)    
General disorders     
contrast extravasation  1 [1]  1/92 (1.09%)  1 0/92 (0.00%)  0
Infections and infestations     
Folliculis  1 [1]  0/92 (0.00%)  0 1/92 (1.09%)  1
Nervous system disorders     
burning  1 [2]  0/92 (0.00%)  0 1/92 (1.09%)  1
Vascular disorders     
heat sensation in the face  1 [2]  1/92 (1.09%)  1 0/92 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Not related, mild
[2]
Possibly related, mild
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Post M. A. Clinical Unit Manager
Organization: Guerbet
Phone: +33 1 45 91 50 00
EMail: corinne.dubourdieu@guerbet-group.com
Layout table for additonal information
Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01026389    
Other Study ID Numbers: DGD 44-045
First Submitted: December 3, 2009
First Posted: December 4, 2009
Results First Submitted: November 14, 2012
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012