Eovist vs. Dotarem Healthy Volunteer MRI

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

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 Overview

• Status: Completed
• Conditions: Transient Severe Arterial Phase Motion
• Intervention / Treatment: Drug: Saline; Drug: gadoxetate disodium; Drug: gadoterate dimeglumine

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eovist (gadoxetate disodium); While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.	Drug: gadoxetate disodium; Other Names: Eovist
Active Comparator: Dotarem (gadoterate dimeglumine); While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.	Drug: gadoterate dimeglumine; Other Names: Dotarem
Active Comparator: Saline; While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.	Drug: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath		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.	following contrast administration, up to 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
O2 Saturation Following Contrast Administration		following contrast administration, up to 5 minutes
Heart Rate Following Contrast Injection	Heart rate following contrast injection	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.	following contrast administration, up to 5 minutes
Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale	no motion artifact; minimal motion artifact; moderate motion artifact; severe motion artifact; extensive motion artifact	following contrast administration, up to 5 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of California, San Diego; University of Wisconsin, Madison
• Investigators: Principal Investigator: Mustafa Bashir, MD, Duke University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): May 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
• Other Study ID Numbers: Pro00059192