Eovist vs. Dotarem Healthy Volunteer MRI

Phase 4

Completed

Interventions: Drug: Saline
Drug: gadoxetate disodium
Drug: gadoterate dimeglumine

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Saline	Saline	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.
Eovist (gadoxetate disodium)	gadoxetate disodium	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)	gadoterate dimeglumine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.