Dyspnea
Conditions
Keywords
gadoxetic acid, transient dyspnea
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.
Interventions
DRUGgadoxetic acid
standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
Sponsors
Bayer
Seoul National University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Transient Dyspnea. | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Transient Dyspnea in Participants With Transient Dyspnea. | 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
| Measure | Time frame | Description |
|---|---|---|
| Liver Stiffness Value | 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. |
Countries
South Korea
Participant flow
Recruitment details
April 2015 to October 2015, patients who are referred to Radiology unit in SNUH for liver MRI scan.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Observe1 |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment South Korea | 60 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
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.
Time frame: during 3 minutes after contrast media administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EOB-MRI | Number of Participants With Transient Dyspnea. | 23 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.
Time frame: during 3 minutes after contrast media administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EOB-MRI | Duration of Transient Dyspnea in Participants With Transient Dyspnea. | 21.5 second | Standard Deviation 13 |
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.
Time frame: in three days after MRI
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EOB-MRI | Liver Stiffness Value | SE MRE | 3.87 kPa | Standard Deviation 1.19 |
| EOB-MRI | Liver Stiffness Value | GRE MRE | 3.76 kPa | Standard Deviation 1.29 |