Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

Dyspnea Clinical Trial

Official title:

Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395991
• Other study ID #: CS_2015_ISS
• Status: Completed
• Start date: April 2015
• Est. completion date: February 2018

Study information

• Verified date: May 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea

Intervention

Drug:
• gadoxetic acid
standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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