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Completed

NCT Number: NCT02395991

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.

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Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GADOXETIC ACID

Drug

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

Other names: eovist, primovist

magnetic resonance imaging (MRI)

Other

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

  1. Number of Participants With Transient Dyspnea.

    Time frame: 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 outcomes

  1. Duration of Transient Dyspnea in Participants With Transient Dyspnea.

    Time frame: 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.

Other outcomes

  1. Liver Stiffness Value

    Time frame: in three days after MRI

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Mar 24, 2015
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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