Eovist vs. Dotarem Healthy Volunteer MRI

NCT02431598 | Completed Phase 4 Results

• 1 other identifier: Pro00059192
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Severe Arterial Phase Motion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• O2 Saturation Following Contrast Administration

  following contrast administration, up to 5 minutes

• 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

  following contrast administration, up to 5 minutes

• Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale

  following contrast administration, up to 5 minutes

Study Arms (3)

Eovist (gadoxetate disodium)

ACTIVE COMPARATOR

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

Dotarem (gadoterate dimeglumine)

ACTIVE COMPARATOR

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

Saline

ACTIVE COMPARATOR

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

Interventions

gadoxetate disodium DRUG

Also known as: Eovist

Eovist (gadoxetate disodium)

gadoterate dimeglumine DRUG

Also known as: Dotarem

Dotarem (gadoterate dimeglumine)

Saline DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- normal renal function (serum eGFR \>60)

You may not qualify if:

• renal impairment
• allergy to gadolinium-based contrast
• metallic implanted devices
• claustrophobia
• pregnant and lactating females

Sponsors & Collaborators

• Duke University: lead
• University of California, San Diego: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

gadolinium ethoxybenzyl DTPA; gadoterate meglumine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Mustafa Bashir
• Organization: Duke University Medical Center

mustafa.bashir@duke.edu

919-684-8111

Study Officials

• Mustafa Bashir, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

US (1)