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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observe1 | Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gadoxetic acid | Drug | standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during 3 minutes after contrast media administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during 3 minutes after contrast media administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | in three days after MRI |
Inclusion Criteria:
Exclusion Criteria:
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Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid.
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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April 2015 to October 2015, patients who are referred to Radiology unit in SNUH for liver MRI scan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observe1 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | during 3 minutes after contrast media administration |
|
1 hour after MRI completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Jeong Min Lee | Seoul National University Hospital | 82-2-2072-3154 | jmsh@snu.ac.kr |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 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. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | second | during 3 minutes after contrast media administration |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | kPa | in three days after MRI |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
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| D013568 | Pathological Conditions, Signs and Symptoms |