CirrhosisPhase 4NCT02854371
Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI
A Phase 4 study testing gadoxetic acid enhanced liver MRI and ICG R15 in people with Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Liver function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- gadoxetic acid enhanced liver MRI and ICG R15
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to May 2018
- Phase
- Phase 4
- 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 with chronic liver disease or liver cirrhosis
- clinically scheduled for gadoxetic acid enhanced liver MRI
- signed informed consent
Who cannot join
- under 18 years
- transarterial chemoembolization, radiation therapy for liver or bile duct within 2 weeks
- systemic chemotherapy within 6 weeks
- any contraindication for contrast enhanced MRI
- hepatic iron deposition at prior imaging
- bile duct obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging
Liver function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. There have been several approaches to measure liver function using gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced liver MRI is clinically used world widely, it would be valuable if we can measure liver function using hepatocyte fraction.
- Conditions
- Cirrhosis
- Being tested
- gadoxetic acid enhanced liver MRI, ICG R15
- Keywords
- gadoxetic acid, T1 map, MRI
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadoxetic acid enhanced liver MRIDrug
Also called Primovist, Eovist
Gadoxetic acid enhanced liver MRI is performed and the standard dose of contrast media (0.025mmol/kg) is administered intravenously at a rate of 1mL/sec. Before and after contrast media injection, T1 map sequence is performed to calculate hepatocyte fraction.
Routine MR sequences (T2WI, T1WI, dual-echo sequence, DWI, MR elastography) are performed according to clinical protocol in the institution.
ICG R15Drug
Also called Indocyanine green retention test
ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| CLD and LC | Experimental | Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group. Receives: Drug: gadoxetic acid enhanced liver MRI; Drug: ICG R15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function assessed by hepatocyte fraction
hepatocyte fraction obtained by T1 map sequence
Measured: 1 month after MRI
Secondary outcomes (2)
Liver function assessed by ICG R15 test
Measured: 3 days after MRI
Hepatocyte uptake rate
calculated hepatic uptake rate from T1 map sequence at MRI
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 posted3 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completionMay 2018
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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- gadoxetic acid MRI and ICG R15 test
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT02854371
- Sponsor's protocol ID
- SNUH-2015-3375
- Status last verified
- Nov 2018
- First submitted
- 31 Jul 2016
- Last updated
- 6 Nov 2018
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02854371
- Acronym / sponsor ID
- SNUH-2015-3375
- Conditions
- Cirrhosis
- Keywords
- gadoxetic acid, T1 map, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Aug 2016 (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 function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. There have been several approaches to measure liver function using gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced liver MRI is clinically used world widely, it would be valuable if we can measure liver function using hepatocyte fraction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- gadoxetic acid MRI and ICG R15 test
| Arm | Type | Receives |
|---|---|---|
| CLD and LC | Experimental | Drug: gadoxetic acid enhanced liver MRI, Drug: ICG R15Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with chronic liver disease or liver cirrhosis
- clinically scheduled for gadoxetic acid enhanced liver MRI
- signed informed consent
Key exclusion criteria (6 listed)
- under 18 years
- transarterial chemoembolization, radiation therapy for liver or bile duct within 2 weeks
- systemic chemotherapy within 6 weeks
- any contraindication for contrast enhanced MRI
- hepatic iron deposition at prior imaging
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 acid enhanced liver MRIAlso: Primovist, EovistGadoxetic acid enhanced liver MRI is performed and the standard dose of contrast media (0.025mmol/kg) is administered intravenously at a rate of 1mL/sec. Before and after contrast media injection, T1 map sequence is performed to calculate hepatocyte fraction. Routine MR sequences (T2WI, T1WI, dual-echo sequence, DWI, MR elastography) are performed according to clinical protocol in the institution. | Drug | CLD and LC |
| ICG R15Also: Indocyanine green retention testICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol. | Drug | CLD and LC |
Primary outcome
Liver function assessed by hepatocyte fraction
Time frame: 1 month after MRI
hepatocyte fraction obtained by T1 map sequence
2 secondary outcomes
Liver function assessed by ICG R15 test
Time frame: 3 days after MRI
Hepatocyte uptake rate
Time frame: 1 month after MRI
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 6 Nov 2018.
- 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 Phase 4 study testing gadoxetic acid enhanced liver MRI and ICG R15 in people with 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 3 inclusion and 6 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 6 Nov 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Liver function assessed by hepatocyte fraction (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 6 Nov 2018.