Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

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

Study Overview

• Status: Completed
• Conditions: Dyspnea
• Intervention / Treatment: Drug: gadoxetic acid; Other: Magnetic resonance imaging (MRI)

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observe1; Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)

Drug: gadoxetic acid; standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration; Other Names: eovist; primovist; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Transient Dyspnea.	A sudden onset irregular breathing pattern after EOB administration, based on MRI k-space data (not participants' symptom). The k-space data was analyzed after the enrollment completion.	during 3 minutes after contrast media administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Transient Dyspnea in Participants With Transient Dyspnea.	The duration of transient dyspnea was analyzed based on the MRI k-space data, using a dedicated software. The analysis using the MRI k-space data was performed after the completion of enrollment.	during 3 minutes after contrast media administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Stiffness Value	liver stiffness value from MR elastography using GRE and SE sequence which is a part of protocol. Both GRE and SE sequences are two different sequences for obtaining MR elastogrphy which measures the stiffness of the liver. The measured liver stiffness is known to be related to the degree of hepatic fibrosis and/or inflammation.	in three days after MRI

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: gadoxetic acid; transient dyspnea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: CS_2015_ISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No