Transient Severe Arterial Phase Motion
Conditions
Brief summary
The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.
Interventions
Sponsors
University of California, San Diego
University of Wisconsin, Madison
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- normal renal function (serum eGFR \>60)
Exclusion criteria
* renal impairment * allergy to gadolinium-based contrast * metallic implanted devices * claustrophobia * pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath | following contrast administration, up to 5 minutes | — |
| Subject-reported Dyspnea, as Measured by Questionnaire Responses | following contrast administration, up to 5 minutes | After 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| O2 Saturation Following Contrast Administration | following contrast administration, up to 5 minutes | — |
| Heart Rate Following Contrast Injection | following contrast administration, up to 5 minutes | Heart rate following contrast injection |
| Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging | following contrast administration, up to 5 minutes | Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test. |
| Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | following contrast administration, up to 5 minutes | 1. no motion artifact 2. minimal motion artifact 3. moderate motion artifact 4. severe motion artifact 5. extensive motion artifact |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eovistvs vs. Dotarem vs. Saline | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Eovistvs vs. Dotarem vs. Saline |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 | 0 / 44 |
Outcome results
Primary
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
Time frame: following contrast administration, up to 5 minutes
Population: All participants received all three drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eovist (Gadoxetate Disodium) | Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath | 28 seconds |
| Dotarem (Gadoterate Dimeglumine) | Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath | 38 seconds |
| Saline | Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath | 35 seconds |
Primary
Subject-reported Dyspnea, as Measured by Questionnaire Responses
After 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.
Time frame: following contrast administration, up to 5 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eovist (Gadoxetate Disodium) | Subject-reported Dyspnea, as Measured by Questionnaire Responses | Question A | 2.4 units on a scale (1-5) | Standard Deviation 1.1 |
| Eovist (Gadoxetate Disodium) | Subject-reported Dyspnea, as Measured by Questionnaire Responses | Question B | 1.3 units on a scale (1-5) | Standard Deviation 0.6 |
| Dotarem (Gadoterate Dimeglumine) | Subject-reported Dyspnea, as Measured by Questionnaire Responses | Question A | 1.8 units on a scale (1-5) | Standard Deviation 1.1 |
| Dotarem (Gadoterate Dimeglumine) | Subject-reported Dyspnea, as Measured by Questionnaire Responses | Question B | 1.1 units on a scale (1-5) | Standard Deviation 0.5 |
| Saline | Subject-reported Dyspnea, as Measured by Questionnaire Responses | Question A | 1.7 units on a scale (1-5) | Standard Deviation 1 |
| Saline | Subject-reported Dyspnea, as Measured by Questionnaire Responses | Question B | 1.1 units on a scale (1-5) | Standard Deviation 0.4 |
Secondary
Heart Rate Following Contrast Injection
Heart rate following contrast injection
Time frame: following contrast administration, up to 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eovist (Gadoxetate Disodium) | Heart Rate Following Contrast Injection | 70 beats per minute | Standard Deviation 12 |
| Dotarem (Gadoterate Dimeglumine) | Heart Rate Following Contrast Injection | 70 beats per minute | Standard Deviation 12 |
| Saline | Heart Rate Following Contrast Injection | 70 beats per minute | Standard Deviation 12 |
Secondary
O2 Saturation Following Contrast Administration
Time frame: following contrast administration, up to 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eovist (Gadoxetate Disodium) | O2 Saturation Following Contrast Administration | 98 percentage | Standard Deviation 2 |
| Dotarem (Gadoterate Dimeglumine) | O2 Saturation Following Contrast Administration | 98 percentage | Standard Deviation 2 |
| Saline | O2 Saturation Following Contrast Administration | 98 percentage | Standard Deviation 2 |
Secondary
Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging
Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test.
Time frame: following contrast administration, up to 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eovist (Gadoxetate Disodium) | Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging | 7 percentage of participants with TSM |
| Dotarem (Gadoterate Dimeglumine) | Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging | 2 percentage of participants with TSM |
| Saline | Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging | 0 percentage of participants with TSM |
Secondary
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
1. no motion artifact 2. minimal motion artifact 3. moderate motion artifact 4. severe motion artifact 5. extensive motion artifact
Time frame: following contrast administration, up to 5 minutes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Eovist (Gadoxetate Disodium) | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Eovist | 2.3 scores on a scale |
| Eovist (Gadoxetate Disodium) | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Dotarem | 2.2 scores on a scale |
| Eovist (Gadoxetate Disodium) | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Normal Saline | 2.1 scores on a scale |
| Dotarem (Gadoterate Dimeglumine) | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Eovist | 2.7 scores on a scale |
| Dotarem (Gadoterate Dimeglumine) | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Dotarem | 2.2 scores on a scale |
| Dotarem (Gadoterate Dimeglumine) | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Normal Saline | 2.3 scores on a scale |
| Saline | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Normal Saline | 2.2 scores on a scale |
| Saline | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Eovist | 2.4 scores on a scale |
| Saline | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Dotarem | 2.3 scores on a scale |
| Last Dynamic Phase | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Eovist | 2.3 scores on a scale |
| Last Dynamic Phase | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Dotarem | 2.3 scores on a scale |
| Last Dynamic Phase | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale | Normal Saline | 2.1 scores on a scale |