Eovist vs. Dotarem Healthy Volunteer MRI

Duke University

Status and phase: Completed; Phase 4

Conditions: Transient Severe Arterial Phase Motion

Treatments: Drug: Saline; Drug: gadoxetate disodium; Drug: gadoterate dimeglumine

Study type: Interventional

Funder types: Other

Identifiers

NCT02431598

Pro00059192

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 3 patient groups

Eovist (gadoxetate disodium)

Active Comparator group

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.

Treatment:

Drug: gadoxetate disodium

Dotarem (gadoterate dimeglumine)

Active Comparator group

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.

Treatment:

Drug: gadoterate dimeglumine

Saline

Active Comparator group

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.

Treatment:

Drug: Saline