Trial Outcomes & Findings for Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease (NCT NCT01026389)

Last Updated: 2012-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

189 participants

Primary outcome timeframe

up to one month

Results posted on

2012-12-11

Participant Flow

Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.

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)

Participant milestones

Participant milestones
Measure	Gadovist Patient received contrast-enhanced MRA with Gadovist	Dotarem Patients received contrast-enhanced MRA with Dotarem
Overall Study STARTED	93	93
Overall Study COMPLETED	88	88
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Gadovist Patient received contrast-enhanced MRA with Gadovist	Dotarem Patients received contrast-enhanced MRA with Dotarem
Overall Study Withdrawal by Subject	1	3
Overall Study change of treatment, patient moved	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gadovist n=93 Participants Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=93 Participants Patients received contrast-enhanced MRA with Dotarem	Total n=186 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Age Continuous	66.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	66.8 years STANDARD_DEVIATION 10.6 • n=7 Participants	66.7 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	75 Participants n=7 Participants	147 Participants n=5 Participants
Region of Enrollment Austria	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants
Region of Enrollment France	16 participants n=5 Participants	20 participants n=7 Participants	36 participants n=5 Participants
Region of Enrollment Germany	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Italy	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Spain	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: up to one month

Population: Per protocol population

Outcome measures

Outcome measures
Measure	Gadovist n=87 Participants Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=86 Participants Patients received contrast-enhanced MRA with Dotarem
Intra-patient Accuracy (Percent Agreement), On-site Data	77.1 percentage of agreement Standard Deviation 19.6	80.6 percentage of agreement Standard Deviation 16.1

SECONDARY outcome

Timeframe: up to one month

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

• 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

Outcome measures

Outcome measures
Measure	Gadovist n=156 images Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=152 images Patients received contrast-enhanced MRA with Dotarem
Intra-patient Accuracy, in Off-site Readings	75.1 percentage of agreement Standard Deviation 15.3	73.9 percentage of agreement Standard Deviation 16.7

SECONDARY outcome

Timeframe: up to one month

Population: per protocol population

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).

Outcome measures

Outcome measures
Measure	Gadovist n=819 Negative segment with gold standard Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=824 Negative segment with gold standard Patients received contrast-enhanced MRA with Dotarem
Specificity	756 negative segments in MRA	763 negative segments in MRA

SECONDARY outcome

Timeframe: up to one month

Population: Per protocol population

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).

Outcome measures

Outcome measures
Measure	Gadovist n=238 positive segment with gold standard Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=264 positive segment with gold standard Patients received contrast-enhanced MRA with Dotarem
Sensitivity	168 positive segment with MRA	191 positive segment with MRA

Adverse Events

Gadovist

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dotarem, Interventional

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gadovist n=92 participants at risk；n=93 participants at risk Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=92 participants at risk；n=93 participants at risk Patients received contrast-enhanced MRA with Dotarem
Cardiac disorders Acute coronary syndrome	0.00% 0/93 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA	1.1% 1/93 • Number of events 1 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA
Nervous system disorders carotid stenosis	0.00% 0/93 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA	1.1% 1/93 • Number of events 1 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA

Other adverse events

Other adverse events
Measure	Gadovist n=92 participants at risk；n=93 participants at risk Patient received contrast-enhanced MRA with Gadovist	Dotarem, Interventional n=92 participants at risk；n=93 participants at risk Patients received contrast-enhanced MRA with Dotarem
Infections and infestations Folliculis	0.00% 0/92 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA	1.1% 1/92 • Number of events 1 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA
General disorders contrast extravasation	1.1% 1/92 • Number of events 1 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA	0.00% 0/92 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA
Nervous system disorders burning	0.00% 0/92 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA	1.1% 1/92 • Number of events 1 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA
Vascular disorders heat sensation in the face	1.1% 1/92 • Number of events 1 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA	0.00% 0/92 • 15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA

Additional Information

Post M. A. Clinical Unit Manager

Guerbet

Phone: +33 1 45 91 50 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60