Eovist vs. Dotarem Healthy Volunteer MRI

• ClinicalTrials.gov Identifier: NCT02431598
• Recruitment Status: Completed
• First Posted: May 1, 2015
• Results First Posted: April 14, 2017
• Last Update Posted: April 14, 2017
• Sponsor: Duke University
• Collaborators: University of California, San Diego; University of Wisconsin, Madison
• Information provided by (Responsible Party): Duke University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Transient Severe Arterial Phase Motion	Drug: gadoxetate disodium; Drug: gadoterate dimeglumine; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact
• Study Start Date: June 2015
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

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 Name: 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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 Outcome Measures :

1. O2 Saturation Following Contrast Administration [ Time Frame: following contrast administration, up to 5 minutes ]
2. Heart Rate Following Contrast Injection [ Time Frame: following contrast administration, up to 5 minutes ]
   Heart rate following contrast injection
3. 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.
4. Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale [ Time Frame: following contrast administration, up to 5 minutes ]
   1. no motion artifact
   2. minimal motion artifact
   3. moderate motion artifact
   4. severe motion artifact
   5. extensive motion artifact

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, North Carolina

Duke Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

University of California, San Diego

University of Wisconsin, Madison

Investigators

• Principal Investigator: Mustafa Bashir, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02431598
• Other Study ID Numbers: Pro00059192
• First Posted: May 1, 2015
• Results First Posted: April 14, 2017
• Last Update Posted: April 14, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action