Duke Medical Center
Durham, North Carolina, 27710, United States
Completed
NCT Number: NCT02431598
Eovist vs. Dotarem Healthy Volunteer MRI
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Gadoxetate Disodium
DrugOther names: Eovist
gadoterate dimeglumine
DrugOther names: Dotarem
Saline
DrugPrimary outcomes
-
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
Time frame: 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 outcomes
-
O2 Saturation Following Contrast Administration
Time frame: following contrast administration, up to 5 minutes
-
Heart Rate Following Contrast Injection
Time frame: 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
Time frame: 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
Time frame: following contrast administration, up to 5 minutes
- no motion artifact
- minimal motion artifact
- moderate motion artifact
- severe motion artifact
- extensive motion artifact
Sponsors and collaborators
Lead sponsor
Duke University
Other
Collaborators
- University of California, San Diego
- University of Wisconsin, Madison
Registry information
Official study title
Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- May 1, 2015
- Registry last updated
- Apr 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.