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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
44
Duke Medical Center
Durham, North Carolina, United States
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
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
O2 Saturation Following Contrast Administration
Time frame: following contrast administration, up to 5 minutes
Heart Rate Following Contrast Injection
Heart rate following contrast injection
Time frame: 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.
Time frame: following contrast administration, up to 5 minutes
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
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