Eovist vs. Dotarem Healthy Volunteer MRI

NCT ID: NCT02431598

Last Updated: 2017-04-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Transient Severe Arterial Phase Motion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

gadoxetate disodium

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

gadoterate dimeglumine

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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gadoxetate disodium

Intervention Type DRUG

gadoterate dimeglumine

Intervention Type DRUG

Saline

Intervention Type DRUG

Other Intervention Names

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Eovist Dotarem

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mustafa Bashir, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00059192

Identifier Type: -

Identifier Source: org_study_id

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