Liver FibrosisNCT01981421
Usefulness of Multi-parametric, Quantitative MR Imaging for Staging of Hepatic Fibrosis in the Patients With Chronic Hepatitis
An observational study of Liver Fibrosis, run by Yonsei University at 1 site in South Korea.
Trial summary
Liver fibrosis has been considered as irreversible change. However, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. Liver biopsy is considered as golden standard for the evaluation of liver fibrosis. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Liver Fibrosis
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have chronic liver disease and who are planned to receive anti-viral treatment.
Who may be able to join
- Patients who had chronic hepatitis
- Patients who underwent liver biopsy within 6 months
- Patients older than 18 years old
Who cannot join
- patient who had pregnancy
- patient 18 or below 18 years old
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Radiology, Yonsei University Health System
Seoul, 120-752
Mi-Suk Park, MD, 82-2-2228-7400, radpms@yuhs.ac
About this study
Liver fibrosis has been considered as irreversible change. However, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. Liver biopsy is considered as golden standard for the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI, and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric MR imaging at the enrollment and one year later to evaluate changes in quantitative values in MR.
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Elastography, MR Elastography, Quantitative imaging
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver fibrosis | patients who had chronic liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment
Elasticity, conventional ADC value, IVIM ADC value, T2* value, T1 rho value will be compared before and after anti-viral treatment
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981421
- Sponsor's protocol ID
- 4-2011-0193
- Status last verified
- Nov 2013
- First submitted
- 4 Nov 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Multi-parametric, Quantitative MR Imaging for Staging of Hepatic Fibrosis in the Patients With Chronic Hepatitis
- ClinicalTrials.gov ID
- NCT01981421
- Acronym / sponsor ID
- 4-2011-0193
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Elastography, MR Elastography, Quantitative imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Nov 2013 (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.
Liver fibrosis has been considered as irreversible change. However, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. Liver biopsy is considered as golden standard for the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI, and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric MR imaging at the enrollment and one year later to evaluate changes in quantitative values in MR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver fibrosis | – | –patients who had chronic liver disease |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have chronic liver disease and who are planned to receive anti-viral treatment.
Key inclusion criteria (3 listed)
- Patients who had chronic hepatitis
- Patients who underwent liver biopsy within 6 months
- Patients older than 18 years old
Key exclusion criteria (2 listed)
- patient who had pregnancy
- patient 18 or below 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment
Time frame: 1 year after enrollment
Elasticity, conventional ADC value, IVIM ADC value, T2* value, T1 rho value will be compared before and after anti-viral treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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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.
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 Liver Fibrosis, run by Yonsei University 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 2 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 11 Nov 2013. 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?
Contact Mi-Suk Park, MD (82-2-2228-7400, radpms@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment (time frame: 1 year after enrollment). 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 11 Nov 2013.