Eovist vs. Dotarem Healthy Volunteer MRI

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact

Conditions
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Transient Severe Arterial Phase Motion

Intervention / Treatment
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* Drug: gadoxetate disodium
* Drug: gadoterate dimeglumine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eovist (gadoxetate disodium)<br>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. | Drug: gadoxetate disodium<br> <br> * Other names: Eovist;|
| Active Comparator: Dotarem (gadoterate dimeglumine)<br>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. | Drug: gadoterate dimeglumine<br> <br> * Other names: Dotarem;|
| Active Comparator: Saline<br>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. | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | no motion artifact minimal motion artifact moderate motion artifact severe motion artifact extensive motion artifact | following contrast administration, up to 5 minutes |