Phase 4
Completed N=44
Eovist vs. Dotarem Healthy Volunteer MRI
Transient Severe Arterial Phase Motion
Source: ClinicalTrials.gov NCT02431598 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath — 28; 38; 35 seconds
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.