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CompletedNCT02395991Updated May 26, 2021Results posted

Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

An observational study in Dyspnea, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspnea

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Keywords

  • gadoxetic acid
  • transient dyspnea
03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 60 is below the median of 122 across 204 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Minors under 18 years old
  • All contraindication to MRI
  • Hypersensitivity to Gd
  • Biliary obstruction
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Observe1

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

    Drug: gadoxetic acid · Other: Magnetic resonance imaging (MRI)

Interventions

  • Druggadoxetic acid

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

    Also known as: eovist, primovist

  • OtherMagnetic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: during 3 minutes after contrast media administration

Secondary outcomes

  1. 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.

    Time frame: during 3 minutes after contrast media administration

Other outcomes

  1. 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.

    Time frame: in three days after MRI

07

Results

Posted May 26, 2021

Participant flow

April 2015 to October 2015, patients who are referred to Radiology unit in SNUH for liver MRI scan.

Participant flow — Overall Study
MilestoneEOB-MRI
Started60
Completed59
Not completed1

Outcome measures

PrimaryNumber 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.

Time frame:
during 3 minutes after contrast media administration
Reported as:
Count of participants · Participants
Number of Participants With Transient Dyspnea.
ParticipantsEOB-MRI
Number of Participants With Transient Dyspnea.23
SecondaryDuration 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.

Time frame:
during 3 minutes after contrast media administration
Reported as:
Mean · second
Duration of Transient Dyspnea in Participants With Transient Dyspnea.
secondObserve1
Duration of Transient Dyspnea in Participants With Transient Dyspnea.21.5 ± 13
Other pre-specifiedLiver 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.

Time frame:
in three days after MRI
Reported as:
Mean · kPa
Liver Stiffness Value
kPaEOB-MRI
SE MRE3.87 ± 1.19
GRE MRE3.76 ± 1.29

Adverse events

Collected over 1 hour after MRI completion. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
EOB-MRI—0/60 (0%)0/60 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Observe1
Mean60.1 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)Observe1
Female25
Male35
Region of Enrollment
Region of Enrollment(participants)Observe1
South Korea60
08

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02395991
Lead sponsor
Seoul National University Hospital
Collaborators
Bayer
Responsible party
Jeong Min Lee (MD, Seoul National University Hospital) — Principal investigator
First posted
Mar 24, 2015
Start date
Apr 2015
Primary completion
Oct 2016
Completion
Feb 2018
Results posted
May 26, 2021
Last update
May 26, 2021

Study contacts

Jeong Min Lee, MD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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