Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

Completed

• Conditions: Dyspnea
• Interventions: Drug: gadoxetic acid; Other: Magnetic resonance imaging (MRI)

• Registration Number: NCT02395991
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Study Start: 2015-04
• Primary Completion: 2016-10
• Study Completion: 2018-02
• Results First Submitted: 2018-11-03
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Results First Posted: 2021-05-26
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

• Minors under 18 years old
• All contraindication to MRI
• Hypersensitivity to Gd
• Biliary obstruction

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Transient Dyspnea.	during 3 minutes after contrast media administration	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Transient Dyspnea in Participants With Transient Dyspnea.	during 3 minutes after contrast media administration	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of