Hepatic FibrosisMRENCT01447667
Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)
A study testing Magnetic resonance elastography in people with Hepatic Fibrosis and Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine: The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Fibrosis, Hepatocellular Carcinoma
- What is being tested?
- Magnetic resonance elastography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as single hypervascular hepatocellular carcinoma initially
- AJCC stage I HCC
- Child-Pugh class A
- Planning radiofrequency ablation for HCC
- Voluntary agreement for this study
Who cannot join
- Decreased kidney function (GFR < 70 mL/min/kg)
- Contraindication to MRI (pacemaker, defibrillator)
- Contrast media hypersensitivity
- Other primary malignancy
- Acute viral hepatitis
- Prior history of liver transplantation
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- Thrombosis in splenic vein or portal vein
- Patients who were enrolled to other clinical trials within 4 weeks
- Other severe chronic disease or psychiatric disease
- Pregnant or milk-feeding women
- Patients with coagulopathy, high risk of bleeding for the liver biopsy
- Patients who disagree to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
The purpose of this study is to determine:
- The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment
- The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis
Read the detailed description
To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment
- Local recurrence/intrahepatic distant recurrence
- Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)
To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis.
- Conditions
- Hepatic Fibrosis, Hepatocellular Carcinoma
- Being tested
- Magnetic resonance elastography
- Keywords
- Hepatic fibrosis, Magnetic resonance elastography, Hepatocellular carcinoma, Recurrence
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance elastographyProcedure or surgery
Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance elastography | Experimental | Magnetic resonance elastography before radiofrequency ablation therapy will be performed. Receives: Procedure: Magnetic resonance elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experienced HCC recurrence after RFA
To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment
Measured: within 2 years after RFA procedure
Secondary outcomes (1)
Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score
To find efficacy of each indicator (MRE, noninvasive serum markers such as APRI, P2/MS) compared to the gold-standard histology score in predicting hepatic fibrosis
Measured: 2 years after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Jung-Hwan Yoon, M.D., Ph.D., Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447667
- Sponsor's protocol ID
- MRE
- Acronym
- MRE
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2011
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
- ClinicalTrials.gov ID
- NCT01447667
- Acronym / sponsor ID
- MRE / MRE
- Conditions
- Hepatic Fibrosis, Hepatocellular Carcinoma
- Keywords
- Hepatic fibrosis, Magnetic resonance elastography, Hepatocellular carcinoma, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 6 Oct 2011 (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 determine:
- The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment
- The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis
Detailed description
To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment
- Local recurrence/intrahepatic distant recurrence
- Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)
To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic 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 elastography | Experimental | Procedure: Magnetic resonance elastographyMagnetic resonance elastography before radiofrequency ablation therapy will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed as single hypervascular hepatocellular carcinoma initially
- AJCC stage I HCC
- Child-Pugh class A
- Planning radiofrequency ablation for HCC
- Voluntary agreement for this study
Key exclusion criteria (12 listed)
- Decreased kidney function (GFR < 70 mL/min/kg)
- Contraindication to MRI (pacemaker, defibrillator)
- Contrast media hypersensitivity
- Other primary malignancy
- Acute viral hepatitis
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 elastographyMagnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue | Procedure or surgery | Magnetic resonance elastography |
Primary outcome
Number of patients who experienced HCC recurrence after RFA
Time frame: within 2 years after RFA procedure
To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment
1 secondary outcome
Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score
Time frame: 2 years after RFA
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 22 Nov 2023.
- 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.
Jung-Hwan Yoon, M.D., Ph.D. study director
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 elastography in people with Hepatic Fibrosis and Hepatocellular Carcinoma, 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 5 inclusion and 12 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 22 Nov 2023. 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?
Number of patients who experienced HCC recurrence after RFA (time frame: within 2 years after RFA procedure). 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 22 Nov 2023.