Expired Study
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Durham, North Carolina 27710


Purpose:

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.


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


Study is Available At:


Original ID:

Pro00059192


NCT ID:

NCT02431598


Secondary ID:


Study Acronym:


Brief Title:

Eovist vs. Dotarem Healthy Volunteer MRI


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

48


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mustafa Bashir, MD
Principal Investigator
Duke University

Study Dates

Start Date:June 2015
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:September 2015
Last Changed Date:September 3, 2015
First Received Date:April 28, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Severity of motion artifacts at arterial phase imaging, measured on a 1-5 scale
Time Frame:following contrast administration, up to 5 minutes
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Presence of motion artifacts at arterial phase imaging
Time Frame:following contrast administration, up to 5 minutes
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in pulse rate
Time Frame:baseline, following contrast administration, up to 5 minutes
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in O2 saturation
Time Frame:baseline, following contrast administration, up to 5 minutes
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Subject-reported dyspnea, a measured by questionnaire
Time Frame:following contrast administration, up to 5 minutes
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:gadoxetate disodium
Arm Name:Eovist (gadoxetate disodium)
Other Name:Eovist
Intervention Type:Drug
Name:gadoterate dimeglumine
Arm Name:Dotarem (gadoterate dimeglumine)
Other Name:Dotarem
Intervention Type:Drug
Name:Saline
Arm Name:Saline

Study Arms

Study Arm Type:Active Comparator
Arm Name:Saline
Description: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.
Study Arm Type:Active Comparator
Arm Name:Dotarem (gadoterate dimeglumine)
Description: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.
Study Arm Type:Active Comparator
Arm Name:Eovist (gadoxetate disodium)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of California, San Diego

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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