Overview

This trial is active, not recruiting.

Condition dyspnea
Treatments gadoxetic acid, magnetic resonance imaging (mri)
Sponsor Seoul National University Hospital
Collaborator Bayer
Start date April 2015
End date October 2016
Trial size 60 participants
Trial identifier NCT02395991, CS_2015_ISS

Summary

The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA administration by obtaining continuous dynamic T1 weighted image data.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)
gadoxetic acid eovist
standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
magnetic resonance imaging (mri)
Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases. precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state.

Primary Outcomes

Measure
incidence of transient dyspnea
time frame: in a year after subject enrollment completion

Secondary Outcomes

Measure
Pattern of transient dyspnea
time frame: in a year after subject enrollment completion

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid, to characterize focal liver lesion or to investigate diffuse liver disease - OR, Liver living donor candidates - AND subjects who sign the informed consent. Exclusion Criteria: - Minors under 18 years old - All contraindication to MRI - Hypersensitivity to Gd - Biliary obstruction

Additional Information

Official title Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI
Principal investigator Jeong Min Lee, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.