FibrosisNCT02480972
Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging
A study testing magnetic resonance imaging in people with Fibrosis and Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2015to 28 Aug 2020
- 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
- patients who are scheduled to undergo liver resection for focal liver lesion
- patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease
- liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection
- AND patients/living donor candidates who sign informed consent
- Exclusion Criteria: Patients who have at least one of followings are excluded.
- Patients who are contraindication for MRI contrast enhanced MRI.
- Premenopausal female patients who are pregnant.
- Patients who are physically compromised to acquire liver MRI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)
The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.
Read the detailed description
In patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included.
Referred patients undergo multiparametric MRI including perfusion, diffusion, elastography and fat quantification before surgery or biopsy.
The pathophysiologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis.
- Being tested
- magnetic resonance imaging
- Keywords
- fibrosis, cirrhosis, MRI
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
Also called MRI
multiparametric MRI as follows:
- diffusion weighted imaging using multiple b-values
- Fat quantification sequence
- perfusion MRI using ECCM agent
- MR elastography ------------------------------------
- routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion)
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging | Other | multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography Receives: Procedure: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Measured: in three years
Secondary outcomes (3)
difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Measured: in three years
difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis
Measured: in three years
monitoring of transient dyspnea after contrast media injection
Measured: in three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start23 Jun 2015
- Primary completion20 Sep 2016
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- 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
- NCT02480972
- Sponsor's protocol ID
- SNUH-082-618
- Status last verified
- Dec 2021
- First submitted
- 18 Jun 2015
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT02480972
- Acronym / sponsor ID
- SNUH-082-618
- Keywords
- fibrosis, cirrhosis, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 25 Jun 2015 (estimated)
- 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.
The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.
Detailed description
In patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included.
Referred patients undergo multiparametric MRI including perfusion, diffusion, elastography and fat quantification before surgery or biopsy.
The pathophysiologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging | Other | Procedure: magnetic resonance imagingmultiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients who are scheduled to undergo liver resection for focal liver lesion
- patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease
- liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection
- AND patients/living donor candidates who sign informed consent
- Exclusion Criteria: Patients who have at least one of followings are excluded.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| magnetic resonance imagingAlso: MRImultiparametric MRI as follows: 1. diffusion weighted imaging using multiple b-values 2. Fat quantification sequence 3. perfusion MRI using ECCM agent 4. MR elastography ------------------------------------ 5. routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion) | Procedure or surgery | Magnetic resonance imaging |
Primary outcome
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Time frame: in three years
3 secondary outcomes
difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis
Time frame: in three years
difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis
Time frame: in three years
monitoring of transient dyspnea after contrast media injection
Time frame: in three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- 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 magnetic resonance imaging in people with Fibrosis and Cirrhosis, 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 8 inclusion and 0 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 17 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis (time frame: in three years). 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 17 Dec 2021.