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Trial record 5 of 44 for:    Gadoxetate

Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

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ClinicalTrials.gov Identifier: NCT02395991
Recruitment Status : Active, not recruiting
First Posted : March 24, 2015
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jeong Min Lee, 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.

Condition or disease Intervention/treatment
Dyspnea Drug: gadoxetic acid Other: Magnetic resonance imaging (MRI)

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI
Study Start Date : April 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. incidence of transient dyspnea [ Time Frame: in a year after subject enrollment completion ]

Secondary Outcome Measures :
  1. Pattern of transient dyspnea [ Time Frame: in a year after subject enrollment completion ]
    duration, start point of transient dyspnea


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395991


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Bayer
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

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Responsible Party: Jeong Min Lee, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02395991     History of Changes
Other Study ID Numbers: CS_2015_ISS
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
gadoxetic acid
transient dyspnea
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms