Trial Outcomes & Findings for Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) (NCT NCT01012674)
NCT ID: NCT01012674
Last Updated: 2016-06-16
Results Overview
Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
2 - 28 days
Results posted on
2016-06-16
Participant Flow
First patient first visit: 28 Oct 2009. Last patient last visit: 12 Oct 2010. Location: radiology departments
A total of 211 patients fulfilling the eligibility criteria were enrolled, of which 187 patients received Dotarem and completed the study. Twenty-four patients did not receive Dotarem and were discontinued prematurely.
Participant milestones
| Measure |
TOF MRA Followed by Dotarem-enhanced MRA
Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.
Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.
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|---|---|
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Overall Study
STARTED
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211
|
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Overall Study
COMPLETED
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187
|
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Overall Study
NOT COMPLETED
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24
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Baseline characteristics by cohort
| Measure |
TOF MRA Followed by Dotarem-enhanced MRA
n=211 Participants
Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.
Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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68 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
44 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Chile
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22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 - 28 daysRate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).
Outcome measures
| Measure |
Dotarem-enhanced MRA
n=2518 Number of arterial segments
Patients benefiting from an MRA after Dotarem IV administration
|
TOF MRA
n=2518 Number of arterial segments
Patients benefiting from an MRA with no contrast medium administration
|
|---|---|---|
|
Technical Failure Rate
Reader 1
|
3.55 percentage of arterial segments
Interval 2.84 to 4.26
|
29.22 percentage of arterial segments
Interval 27.48 to 30.96
|
|
Technical Failure Rate
Reader 2
|
1.57 percentage of arterial segments
Interval 1.09 to 2.04
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17.65 percentage of arterial segments
Interval 16.19 to 19.11
|
|
Technical Failure Rate
Reader 3
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1.68 percentage of arterial segments
Interval 1.19 to 2.17
|
23.07 percentage of arterial segments
Interval 21.46 to 24.68
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PRIMARY outcome
Timeframe: 2-42 daysRate of true stenotic segments (i.e. with stenosis \>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).
Outcome measures
| Measure |
Dotarem-enhanced MRA
n=2532 Number of arterial segments
Patients benefiting from an MRA after Dotarem IV administration
|
TOF MRA
n=2532 Number of arterial segments
Patients benefiting from an MRA with no contrast medium administration
|
|---|---|---|
|
Sensitivity
Reader 1
|
70.65 percentage of arterial segments
Interval 61.35 to 79.96
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65.22 percentage of arterial segments
Interval 55.48 to 74.95
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Sensitivity
Reader 2
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69.57 percentage of arterial segments
Interval 60.16 to 78.97
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73.91 percentage of arterial segments
Interval 64.94 to 82.89
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|
Sensitivity
Reader 3
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75.00 percentage of arterial segments
Interval 66.15 to 83.85
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66.30 percentage of arterial segments
Interval 56.65 to 75.96
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PRIMARY outcome
Timeframe: 2 - 42 daysRate of true non-stenotic segments (i.e. without stenosis \>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).
Outcome measures
| Measure |
Dotarem-enhanced MRA
n=2532 Number of arterial segments
Patients benefiting from an MRA after Dotarem IV administration
|
TOF MRA
n=2532 Number of arterial segments
Patients benefiting from an MRA with no contrast medium administration
|
|---|---|---|
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Specificity
Reader 1
|
98.03 percentage of arterial segments
Interval 97.48 to 98.58
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84.34 percentage of arterial segments
Interval 82.9 to 85.79
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Specificity
Reader 2
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98.40 percentage of arterial segments
Interval 97.9 to 98.9
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89.51 percentage of arterial segments
Interval 88.29 to 90.72
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Specificity
Reader 3
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98.61 percentage of arterial segments
Interval 98.14 to 99.07
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88.40 percentage of arterial segments
Interval 87.13 to 89.67
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Adverse Events
Dotarem-enhanced MRA
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
TOF MRA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Computerized Tomography Angiography (CTA)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Discontinued Without Dotarem Administration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dotarem-enhanced MRA
n=187 participants at risk
Patients benefiting from an MRA after Dotarem IV administration
|
TOF MRA
n=187 participants at risk
Patients benefiting from an MRA with no contrast medium administration
|
Computerized Tomography Angiography (CTA)
n=187 participants at risk
Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
|
Patients Discontinued Without Dotarem Administration
n=24 participants at risk
Patients withdrawn from the study before Dotarem IV administration whatever the reason
|
|---|---|---|---|---|
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Immune system disorders
Hypersensitivity
|
0.53%
1/187 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/24 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.53%
1/187 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/24 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
Other adverse events
| Measure |
Dotarem-enhanced MRA
n=187 participants at risk
Patients benefiting from an MRA after Dotarem IV administration
|
TOF MRA
n=187 participants at risk
Patients benefiting from an MRA with no contrast medium administration
|
Computerized Tomography Angiography (CTA)
n=187 participants at risk
Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
|
Patients Discontinued Without Dotarem Administration
n=24 participants at risk
Patients withdrawn from the study before Dotarem IV administration whatever the reason
|
|---|---|---|---|---|
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Nervous system disorders
Headache
|
1.1%
2/187 • Number of events 2 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/24 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
2/187 • Number of events 2 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/24 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
0.00%
0/187 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
|
Additional Information
Dr Pierre Desché, MD - VP Head of Development, Medical and Regulatory Affairs
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