Phase 4
N=44
Eovist vs. Dotarem Healthy Volunteer MRI
Transient Severe Arterial Phase Motion
Bottom Line
View on ClinicalTrials.gov: NCT02431598 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath — 28; 38; 35 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- gadoxetate disodium (Drug); gadoterate dimeglumine (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath |
28; 38; 35 | — |
| PRIMARY Subject-reported Dyspnea, as Measured by Questionnaire Responses |
2.4; 1.8; 1.7; 1.3; 1.1; 1.1 | — |
| SECONDARY O2 Saturation Following Contrast Administration |
98; 98; 98 | — |
| SECONDARY Heart Rate Following Contrast Injection |
70; 70; 70 | — |
| SECONDARY Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging |
7; 2; 0 | — |
| SECONDARY Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale |
2.3; 2.7; 2.4; 2.3; 2.1; 2.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02431598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.