Liver CirrhosisPriMPaNCT01501240
Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver
An observational study of Liver Cirrhosis and Carcinoma, Hepatocellular, run by Jae Ho Byun at 2 sites in South Korea.
Trial summary
A prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as standard of reference Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Carcinoma, Hepatocellular
- How many people
- 0 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2012to Aug 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month
Who may be able to join
- Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data
- Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data
Who cannot join
- Patients under 20 years of age
- Patients who have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced MR
- Patients who underwent transarterial chemotherapy or radiofrequency ablation
- Women who are pregnant, lactating or who are of childbearing potential
- Patients with any physical or mental status than interferes with the signing of informed consent
- Patients with a contraindication for MR
- Patients with impaired renal function (e.g. acute renal failure or eGFR < 30 ml/min/1.73m2) or patients on dialysis
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul, 138-736
Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
Official title: Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver
A prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as standard of reference
Read the detailed description
Liver cirrhosis is a progressive, diffuse disease of the liver characterized by hepatocyte necrosis, fibrosis, distortion of the normal hepatic architecture and a spectrum of nodular lesions that includes regenerative nodules (RN), dysplastic nodules (DN) and hepatocellular carcinomas (HCC). Since HCC is the leading cause of death among the patients with liver cirrhosis, Early and accurate diagnosis of HCC and its precursors by using optimal imaging technique is critical for its treatment and management.
Recently state-of-the-art magnetic resonance (MR) imaging with gadoxetic acid, which works both an extracellular and hepatocyte-specific contrast agent, has been increasing used to evaluate the patients with liver cirrhosis. Several studies correlated gadoxetic acid-enhanced MR of HCC and hepatocellular nodules with the pathology from biopsy or surgical resection specimens. However, all of those studies are limited by its lack of complete correlation between pathologic and imaging findings and the resulting bias being toward the positive studies. Ideally, the use of whole explant pathologic correlation would be helpful for exact characterization of HCC and its precursors on gadoxetic acid-enhanced MR.
The question of our study is how accurate gadoxetic acid-enhanced MR is in the evaluation of the patients with cirrhotic liver to detect HCC and dysplastic nodules and, by using thin-section whole-explant correlation following liver transplantation as the reference standard.
- Conditions
- Liver Cirrhosis, Carcinoma, Hepatocellular
- Keywords
- Magnetic resonance image, gadoxetic acid, hepatocellular carcinoma, liver cirrhosis
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular
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 cirrhosis, liver transplantation | Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month will be eligible population in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as the standard of reference
Measured: Within the first week after liver explantation
Secondary outcomes (3)
Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference
Measured: Within the first week after liver explantation
Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules
To assess the diagnostic sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules in the cirrhotic liver, using thin-section whole-explant as standard of reference
Measured: Within one week after liver transplantation
To characterize borderline hepatocelluar nodules
To characterize borderline hepatocelluar nodules (i.e.,1-3cm sized nodules without arterial hypervascularity) in the cirrhotic liver detected on hepatobiliary phase of gadoxetic acid-enhanced MR
Measured: Within one week after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jae Ho Byun
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Jae Ho Byun, Asan Medical Center
- Investigators
- Jae Ho Byun, MD, PhD, Principal investigator, University of Ulsan College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501240
- Sponsor's protocol ID
- AMC-2011-0797
- Acronym
- PriMPa
- Status last verified
- Jan 2014
- First submitted
- 26 Dec 2011
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kudo M. Will Gd-EOB-MRI change the diagnostic algorithm in hepatocellular carcinoma? Oncology. 2010 Jul;78 Suppl 1:87-93. doi: 10.1159/000315235. Epub 2010 Jul 8.
PubMed 20616589Zech CJ, Reiser MF, Herrmann KA. Imaging of hepatocellular carcinoma by computed tomography and magnetic resonance imaging: state of the art. Dig Dis. 2009;27(2):114-24. doi: 10.1159/000218343. Epub 2009 Jun 22.
PubMed 19546549Tanimoto A, Lee JM, Murakami T, Huppertz A, Kudo M, Grazioli L. Consensus report of the 2nd International Forum for Liver MRI. Eur Radiol. 2009 Oct;19 Suppl 5:S975-89. doi: 10.1007/s00330-009-1624-y.
PubMed 19851766
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver
- ClinicalTrials.gov ID
- NCT01501240
- Acronym / sponsor ID
- PriMPa / AMC-2011-0797
- Conditions
- Liver Cirrhosis, Carcinoma, Hepatocellular
- Keywords
- Magnetic resonance image, gadoxetic acid, hepatocellular carcinoma, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jae Ho ByunUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 29 Dec 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.
A prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as standard of reference
Detailed description
Liver cirrhosis is a progressive, diffuse disease of the liver characterized by hepatocyte necrosis, fibrosis, distortion of the normal hepatic architecture and a spectrum of nodular lesions that includes regenerative nodules (RN), dysplastic nodules (DN) and hepatocellular carcinomas (HCC). Since HCC is the leading cause of death among the patients with liver cirrhosis, Early and accurate diagnosis of HCC and its precursors by using optimal imaging technique is critical for its treatment and management.
Recently state-of-the-art magnetic resonance (MR) imaging with gadoxetic acid, which works both an extracellular and hepatocyte-specific contrast agent, has been increasing used to evaluate the patients with liver cirrhosis. Several studies correlated gadoxetic acid-enhanced MR of HCC and hepatocellular nodules with the pathology from biopsy or surgical resection specimens. However, all of those studies are limited by its lack of complete correlation between pathologic and imaging findings and the resulting bias being toward the positive studies. Ideally, the use of whole explant pathologic correlation would be helpful for exact characterization of HCC and its precursors on gadoxetic acid-enhanced MR.
The question of our study is how accurate gadoxetic acid-enhanced MR is in the evaluation of the patients with cirrhotic liver to detect HCC and dysplastic nodules and, by using thin-section whole-explant correlation following liver transplantation as the reference standard.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver cirrhosis, liver transplantation | – | –Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month will be eligible population in the study |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month
Key inclusion criteria (2 listed)
- Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data
- Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data
Key exclusion criteria (7 listed)
- Patients under 20 years of age
- Patients who have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced MR
- Patients who underwent transarterial chemotherapy or radiofrequency ablation
- Women who are pregnant, lactating or who are of childbearing potential
- Patients with any physical or mental status than interferes with the signing of 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.
Primary outcome
Diagnostic sensitivity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as the standard of reference
Time frame: Within the first week after liver explantation
3 secondary outcomes
Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference
Time frame: Within the first week after liver explantation
Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules
Time frame: Within one week after liver transplantation
To characterize borderline hepatocelluar nodules
Time frame: Within one week after liver transplantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Background: PubMed 20616589Kudo M. Will Gd-EOB-MRI change the diagnostic algorithm in hepatocellular carcinoma? Oncology. 2010 Jul;78 Suppl 1:87-93. doi: 10.1159/000315235. Epub 2010 Jul 8.
- Background: PubMed 19546549Zech CJ, Reiser MF, Herrmann KA. Imaging of hepatocellular carcinoma by computed tomography and magnetic resonance imaging: state of the art. Dig Dis. 2009;27(2):114-24. doi: 10.1159/000218343. Epub 2009 Jun 22.
- Background: PubMed 19851766Tanimoto A, Lee JM, Murakami T, Huppertz A, Kudo M, Grazioli L. Consensus report of the 2nd International Forum for Liver MRI. Eur Radiol. 2009 Oct;19 Suppl 5:S975-89. doi: 10.1007/s00330-009-1624-y.
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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.
Jae Ho Byun, MD, PhD principal investigator
University of Ulsan College of Medicine, Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Carcinoma, Hepatocellular, run by Jae Ho Byun at 2 sites 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnostic sensitivity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as the standard of reference (time frame: Within the first week after liver explantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01501240, which also lists 3 linked publications.
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 28 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.