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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| University of Wisconsin, Madison | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eovist (gadoxetate disodium) | Active Comparator | While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. |
|
| Dotarem (gadoterate dimeglumine) | Active Comparator | While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. |
|
| Saline | Active Comparator | While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gadoxetate disodium | Drug |
|
| |
| gadoterate dimeglumine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | following contrast administration, up to 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| O2 Saturation Following Contrast Administration | following contrast administration, up to 5 minutes | |
| Heart Rate Following Contrast Injection | Heart rate following contrast injection | following contrast administration, up to 5 minutes |
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Inclusion Criteria:
- normal renal function (serum eGFR >60)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Bashir, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eovist Crossover to Dotarem Crossover to Saline | Subjects received the agents in this particular order during their MRI. |
| FG001 | Dotarem Crossover to Eovist Crossover to Saline | Subjects received the agents in this particular order during their MRI. |
| FG002 | Eovist Crossover to Saline Crossover to Dotarem | Subjects received the agents in this particular order during their MRI. |
| FG003 | Saline Crossover to Dotarem Crossover to Eovist | Subjects received the agents in this particular order during their MRI. |
| FG004 | Dotarem Crossover to Saline Crossover to Eovist | Subjects received the agents in this particular order during their MRI. |
| FG005 | Saline Crossover to Eovist Crossover to Dotarem | Subjects received the agents in this particular order during their MRI. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eovistvs vs. Dotarem vs. Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath | All participants received all three drugs. | Posted | Median | Full Range | seconds | following contrast administration, up to 5 minutes |
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eovist (Gadoxetate Disodium) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mustafa Bashir | Duke University Medical Center | 919-684-8111 | mustafa.bashir@duke.edu |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
| C072417 | gadoterate meglumine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
|
|
| Saline | Drug |
|
| 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. | following contrast administration, up to 5 minutes |
| Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale |
| following contrast administration, up to 5 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale (1-5) | following contrast administration, up to 5 minutes |
|
|
|
| Secondary | O2 Saturation Following Contrast Administration | Posted | Mean | Standard Deviation | percentage | following contrast administration, up to 5 minutes |
|
|
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| Secondary | Heart Rate Following Contrast Injection | Heart rate following contrast injection | Posted | Mean | Standard Deviation | beats per minute | following contrast administration, up to 5 minutes |
|
|
|
| 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. | Posted | Number | percentage of participants with TSM | following contrast administration, up to 5 minutes |
|
|
|
| Secondary | Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale |
| Posted | Mean | Full Range | scores on a scale | following contrast administration, up to 5 minutes |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Dotarem (Gadoterate Dimeglumine) | 0 | 44 | 0 | 44 |
| EG002 | Saline | 0 | 44 | 0 | 44 |
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| D017670 |
| Sodium Compounds |
|
| Normal Saline |
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| Dotarem |
|