CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
gadoxetate disodium +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02431598
NCT02431598Phase 4Completed

Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact

Duke University·interventional·Posted May 1, 2015·Updated Apr 14, 2017

In Brief

A Phase 4 clinical trial evaluating gadoxetate disodium, gadoterate dimeglumine, and 1 other intervention for Transient Severe Arterial Phase Motion. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 1, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.2 years ago

Interventions

gadoxetate disodiumdrug

gadoterate dimegluminedrug

Salinedrug