Trial Outcomes & Findings for Eovist vs. Dotarem Healthy Volunteer MRI (NCT NCT02431598)
NCT ID: NCT02431598
Last Updated: 2017-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
following contrast administration, up to 5 minutes
Results posted on
2017-04-14
Participant Flow
Participant milestones
| Measure |
Eovist Crossover to Dotarem Crossover to Saline
Subjects received the agents in this particular order during their MRI.
|
Dotarem Crossover to Eovist Crossover to Saline
Subjects received the agents in this particular order during their MRI.
|
Eovist Crossover to Saline Crossover to Dotarem
Subjects received the agents in this particular order during their MRI.
|
Saline Crossover to Dotarem Crossover to Eovist
Subjects received the agents in this particular order during their MRI.
|
Dotarem Crossover to Saline Crossover to Eovist
Subjects received the agents in this particular order during their MRI.
|
Saline Crossover to Eovist Crossover to Dotarem
Subjects received the agents in this particular order during their MRI.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
9
|
7
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
9
|
9
|
7
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eovist vs. Dotarem Healthy Volunteer MRI
Baseline characteristics by cohort
| Measure |
Eovistvs vs. Dotarem vs. Saline
n=44 Participants
|
|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: following contrast administration, up to 5 minutesPopulation: All participants received all three drugs.
Outcome measures
| Measure |
Eovist (Gadoxetate Disodium)
n=44 Participants
|
Dotarem (Gadoterate Dimeglumine)
n=44 Participants
|
Saline
n=44 Participants
|
Last Dynamic Phase
Imaging obtained during late dynamic phase
|
|---|---|---|---|---|
|
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
|
28 seconds
Interval 8.0 to 117.0
|
38 seconds
Interval 23.0 to 125.0
|
35 seconds
Interval 20.0 to 108.0
|
—
|
PRIMARY outcome
Timeframe: following contrast administration, up to 5 minutesAfter each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.
Outcome measures
| Measure |
Eovist (Gadoxetate Disodium)
n=44 Participants
|
Dotarem (Gadoterate Dimeglumine)
n=44 Participants
|
Saline
n=44 Participants
|
Last Dynamic Phase
Imaging obtained during late dynamic phase
|
|---|---|---|---|---|
|
Subject-reported Dyspnea, as Measured by Questionnaire Responses
Question A
|
2.4 units on a scale (1-5)
Standard Deviation 1.1
|
1.8 units on a scale (1-5)
Standard Deviation 1.1
|
1.7 units on a scale (1-5)
Standard Deviation 1.0
|
—
|
|
Subject-reported Dyspnea, as Measured by Questionnaire Responses
Question B
|
1.3 units on a scale (1-5)
Standard Deviation 0.6
|
1.1 units on a scale (1-5)
Standard Deviation 0.5
|
1.1 units on a scale (1-5)
Standard Deviation 0.4
|
—
|
SECONDARY outcome
Timeframe: following contrast administration, up to 5 minutesOutcome measures
| Measure |
Eovist (Gadoxetate Disodium)
n=44 Participants
|
Dotarem (Gadoterate Dimeglumine)
n=44 Participants
|
Saline
n=44 Participants
|
Last Dynamic Phase
Imaging obtained during late dynamic phase
|
|---|---|---|---|---|
|
O2 Saturation Following Contrast Administration
|
98 percentage
Standard Deviation 2
|
98 percentage
Standard Deviation 2
|
98 percentage
Standard Deviation 2
|
—
|
SECONDARY outcome
Timeframe: following contrast administration, up to 5 minutesHeart rate following contrast injection
Outcome measures
| Measure |
Eovist (Gadoxetate Disodium)
n=44 Participants
|
Dotarem (Gadoterate Dimeglumine)
n=44 Participants
|
Saline
n=44 Participants
|
Last Dynamic Phase
Imaging obtained during late dynamic phase
|
|---|---|---|---|---|
|
Heart Rate Following Contrast Injection
|
70 beats per minute
Standard Deviation 12
|
70 beats per minute
Standard Deviation 12
|
70 beats per minute
Standard Deviation 12
|
—
|
SECONDARY outcome
Timeframe: following contrast administration, up to 5 minutesArterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test.
Outcome measures
| Measure |
Eovist (Gadoxetate Disodium)
n=44 Participants
|
Dotarem (Gadoterate Dimeglumine)
n=44 Participants
|
Saline
n=44 Participants
|
Last Dynamic Phase
Imaging obtained during late dynamic phase
|
|---|---|---|---|---|
|
Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging
|
7 percentage of participants with TSM
|
2 percentage of participants with TSM
|
0 percentage of participants with TSM
|
—
|
SECONDARY outcome
Timeframe: following contrast administration, up to 5 minutes1. no motion artifact 2. minimal motion artifact 3. moderate motion artifact 4. severe motion artifact 5. extensive motion artifact
Outcome measures
| Measure |
Eovist (Gadoxetate Disodium)
n=44 Participants
|
Dotarem (Gadoterate Dimeglumine)
n=44 Participants
|
Saline
n=44 Participants
|
Last Dynamic Phase
n=44 Participants
Imaging obtained during late dynamic phase
|
|---|---|---|---|---|
|
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
Eovist
|
2.3 scores on a scale
Interval 1.0 to 5.0
|
2.7 scores on a scale
Interval 1.0 to 5.0
|
2.4 scores on a scale
Interval 1.0 to 5.0
|
2.3 scores on a scale
Interval 1.0 to 5.0
|
|
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
Normal Saline
|
2.1 scores on a scale
Interval 1.0 to 5.0
|
2.3 scores on a scale
Interval 1.0 to 5.0
|
2.2 scores on a scale
Interval 1.0 to 5.0
|
2.1 scores on a scale
Interval 1.0 to 5.0
|
|
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
Dotarem
|
2.2 scores on a scale
Interval 1.0 to 5.0
|
2.2 scores on a scale
Interval 1.0 to 5.0
|
2.3 scores on a scale
Interval 1.0 to 5.0
|
2.3 scores on a scale
Interval 1.0 to 5.0
|
Adverse Events
Eovist (Gadoxetate Disodium)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dotarem (Gadoterate Dimeglumine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place