Trial Outcomes & Findings for Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI (NCT NCT02395991)
NCT ID: NCT02395991
Last Updated: 2021-05-26
Results Overview
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.
COMPLETED
60 participants
during 3 minutes after contrast media administration
2021-05-26
Participant Flow
April 2015 to October 2015, patients who are referred to Radiology unit in SNUH for liver MRI scan.
Participant milestones
| Measure |
EOB-MRI
Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)
gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
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|---|---|
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Overall Study
STARTED
|
60
|
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Overall Study
COMPLETED
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59
|
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI
Baseline characteristics by cohort
| Measure |
Observe1
n=60 Participants
Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)
gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
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|---|---|
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Age, Continuous
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60.1 years
STANDARD_DEVIATION 11.3 • n=93 Participants
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Sex: Female, Male
Female
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25 Participants
n=93 Participants
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Sex: Female, Male
Male
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35 Participants
n=93 Participants
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Region of Enrollment
South Korea
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60 participants
n=93 Participants
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PRIMARY outcome
Timeframe: during 3 minutes after contrast media administrationA 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.
Outcome measures
| Measure |
EOB-MRI
n=59 Participants
Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)
gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
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|---|---|
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Number of Participants With Transient Dyspnea.
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23 Participants
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SECONDARY outcome
Timeframe: during 3 minutes after contrast media administrationThe 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.
Outcome measures
| Measure |
EOB-MRI
n=59 Participants
Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)
gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
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|---|---|
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Duration of Transient Dyspnea in Participants With Transient Dyspnea.
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21.5 second
Standard Deviation 13
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OTHER_PRE_SPECIFIED outcome
Timeframe: in three days after MRIliver 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.
Outcome measures
| Measure |
EOB-MRI
n=59 Participants
Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)
gadoxetic acid: standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
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|---|---|
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Liver Stiffness Value
SE MRE
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3.87 kPa
Standard Deviation 1.19
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Liver Stiffness Value
GRE MRE
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3.76 kPa
Standard Deviation 1.29
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Adverse Events
EOB-MRI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Jeong Min Lee
Seoul National University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place