MedTrace Logo

Eovist vs. Dotarem Healthy Volunteer MRI

NCT02431598 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-04-14

Study results available
· View outcomes & findings →

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

Interventions

DRUG

gadoxetate disodium

DRUG

gadoterate dimeglumine

DRUG

Saline

Sponsors & Collaborators

Principal Investigators

  • Mustafa Bashir, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431598 on ClinicalTrials.gov