CirrhosisNCT03085342
Evaluation of Hepatic Fibrosis on Multiparametric MRI
A study testing Liver MRI in people with Cirrhosis and Hepatitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Apr 2017to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
- Or transplant recipient for viral hepatitis and on anti-viral agent medication
- AND scheduled for liver resection, biopsy or transient elastography
- AND signed informed consent
Who cannot join
- younger than 18 years
- any contra-indication for contrast-enhanced MRI
- pregnant or nursing women
- biliary obstruction
- unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hepatic Fibrosis on Multiparametric MRI Including Portal Flow Measurement Using Dual-input Software: Preliminary Study
As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.
- Being tested
- Liver MRI
- Keywords
- liver, fibrosis, MRI
- Medical subject headings
- Fibrosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver MRIDiagnostic test
Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.
| Study group | Role | What they receive |
|---|---|---|
| Liver MRI | Experimental | Liver MRI including noncontrast (precontrast) flow measurement, DCE, DWI using multiple b-values, MRE and MR fat quantification. Receives: Diagnostic Test: Liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic fibrosis stage
F0-1 vs. F2-4 using multiparametric MRI
Measured: 1 month after MRI
Secondary outcomes (2)
presence of varix
presence of esophageal or gastric varices using multiparametric MRI
Measured: 1 month after MRI
comparison of portal flow measurement
comparison of portal flow measurement using DCE and precontrast flow measurement
Measured: 1 month after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start4 Apr 2017
- Primary completion25 Sep 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- 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
- NCT03085342
- Sponsor's protocol ID
- SNUH-2015-2993
- Status last verified
- Oct 2020
- First submitted
- 14 Mar 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatic Fibrosis on Multiparametric MRI Including Portal Flow Measurement Using Dual-input Software: Preliminary Study
- ClinicalTrials.gov ID
- NCT03085342
- Acronym / sponsor ID
- SNUH-2015-2993
- Keywords
- liver, fibrosis, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver MRI | Experimental | Diagnostic Test: Liver MRILiver MRI including noncontrast (precontrast) flow measurement, DCE, DWI using multiple b-values, MRE and MR fat quantification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
- Or transplant recipient for viral hepatitis and on anti-viral agent medication
- AND scheduled for liver resection, biopsy or transient elastography
- AND signed informed consent
Key exclusion criteria (5 listed)
- younger than 18 years
- any contra-indication for contrast-enhanced MRI
- pregnant or nursing women
- biliary obstruction
- unable or unwilling to give informed consent
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 |
|---|---|---|
| Liver MRIMultiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification. | Diagnostic test | Liver MRI |
Primary outcome
hepatic fibrosis stage
Time frame: 1 month after MRI
F0-1 vs. F2-4 using multiparametric MRI
2 secondary outcomes
presence of varix
Time frame: 1 month after MRI
comparison of portal flow measurement
Time frame: 1 month after MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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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?
A study testing Liver MRI in people with Cirrhosis and Hepatitis, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. 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?
Results are not available in the source record.
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?
hepatic fibrosis stage (time frame: 1 month after MRI). 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 20 Oct 2020.