DyspneaNCT02395991
Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI
An observational study of Dyspnea, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- gadoxetic acid and Magnetic resonance imaging (MRI)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Feb 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid.
Who may be able to join
- 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.
Who cannot join
- Minors under 18 years old
- All contraindication to MRI
- Hypersensitivity to Gd
- Biliary obstruction
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA administration by obtaining continuous dynamic T1 weighted image data.
- Conditions
- Dyspnea
- Being tested
- gadoxetic acid, Magnetic resonance imaging (MRI)
- Keywords
- gadoxetic acid, transient dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadoxetic acidDrug
Also called eovist, primovist
standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
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.
| Study group | Role | What they receive |
|---|---|---|
| Observe1 | Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI) Receives: Drug: gadoxetic acid; Other: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: during 3 minutes after contrast media administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395991
- Sponsor's protocol ID
- CS_2015_ISS
- Status last verified
- May 2021
- First submitted
- 18 Mar 2015
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI
- ClinicalTrials.gov ID
- NCT02395991
- Acronym / sponsor ID
- CS_2015_ISS
- Conditions
- Dyspnea
- Keywords
- gadoxetic acid, transient dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 26 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA administration by obtaining continuous dynamic T1 weighted image data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observe1 | – | Drug: gadoxetic acid, Other: Magnetic resonance imaging (MRI)Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Minors under 18 years old
- All contraindication to MRI
- Hypersensitivity to Gd
- Biliary obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gadoxetic acidAlso: eovist, primoviststandard dose of gadoxetic acid (0.025mmol/kg) intravenous administration | Drug | Observe1 |
| 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. | Other | Observe1 |
Primary outcome
Number of Participants With Transient Dyspnea.
Time frame: 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.
1 secondary outcome
Duration of Transient Dyspnea in Participants With Transient Dyspnea.
Time frame: during 3 minutes after contrast media administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Transient Dyspnea. (time frame: during 3 minutes after contrast media administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.