HccNCT03045419
Added Value of Gadoxetic Acid-enhanced Liver MRI
An observational study of Hcc and Diagnosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- gadoxetic acid-enhanced liver MRI
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Dec 2009to 31 Dec 2016
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients at a risk of HCC and had focal liver lesion at CT.
Who may be able to join
- patients with chronic hepatitis B or cirrhosis of any etiology
- signed informed consent AND
- being referred to radiology department for gadoxetic acid-enhanced MRI due to small nodule (10-19mm) at contrast-enhanced CT scan within 30 days as an radiofrequency ablation (RFA) work-up OR
- being referred to radiology department for percutaneous biopsy for atypical hepatic nodules (≥20mm) detected at contrast-enhanced CT within 30 days before biopsy
Who cannot join
- Any contraindication for MRI and MR contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Added Value of Gadoxetic Acid-enhanced Liver Magnetic Resonance Imaging for Diagnosis of Small (10-19 mm) or Atypical Hepatic Nodules at Contrast-enhanced Computed Tomography: A Prospective Study
It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC.
Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.
Read the detailed description
In terms of confirmative diagnosis, HCC is unique compared with other malignant tumors, as it can be diagnosed noninvasively based on its characteristic imaging features, that is, arterial hyperenhancement (washin) and hypoenhancement (washout) on portal or delayed phase at contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) using extracellular contrast media (ECCM). According to Liver Imaging Reporting and Data System (LI-RADS), hypointensity and isointensity on hepatobiliary phase (HBP) at gadoxetic acid-enhanced MRI are suggestive of malignancy and benignity, respectively, and those features are uniquely provided by only hepatocyte-specific contrast agent. However, these features are not included in diagnostic criteria because of its non-specificity, and indeed, gadoxetic acid-enhanced MRI is not yet included in AASLD and EASL guidelines as a diagnostic modality. If gadoxetic acid-enhanced MRI would provide better performance to diagnose HCC than CT, gadoxetic acid-enhanced MRI should be considered as a next step before biopsy in those small and/or atypical nodules to avoid potential diagnostic pitfall and morbidity, which is currently depending on physicians' decision. Thus, it would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC.
Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.
- Being tested
- gadoxetic acid-enhanced liver MRI
- Keywords
- MRI, gadoxetic acid, CT
- Medical subject headings
- Carcinoma, Hepatocellular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadoxetic acid-enhanced liver MRIProcedure or surgery
liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid
| Study group | Role | What they receive |
|---|---|---|
| Patients group | * with small hepatic nodules (10-19mm) or atypical hepatic nodule (= or > 20mm) and high-risk group of HCC
* scheduled for gadoxetic acid-enhanced liver MRI or liver nodule biopsy Receives: Procedure: gadoxetic acid-enhanced liver MRI | |
| Living liver donor candidates | * living liver donor candidates without history of liver disease
* schedule for gadoxetic acid-enhanced liver MRI as preoperative workup
* only used for control of normal liver parenchymal enhancement on hepatobiliary phase Receives: Procedure: gadoxetic acid-enhanced liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity to diagnose HCC, per-nodule base
sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base
Measured: 12 months after MRI
Secondary outcomes (3)
specificity to diagnose HCC, per-nodule base
specificity of HCC on CT and gadoxetic acid MRI, per-nodule base
Measured: 12 months after MRI
sensitivity to diagnose HCC, per-patient base
sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base
Measured: 12 months after MRI
specificity to diagnose HCC, per-patient base
specificity of HCC on CT and gadoxetic acid MRI, per-patient base
Measured: 12 months after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start29 Dec 2009
- Primary completion24 Nov 2013
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HccStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- 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
- NCT03045419
- Sponsor's protocol ID
- SNUH-2009-5441
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Gadoxetic Acid-enhanced Liver Magnetic Resonance Imaging for Diagnosis of Small (10-19 mm) or Atypical Hepatic Nodules at Contrast-enhanced Computed Tomography: A Prospective Study
- ClinicalTrials.gov ID
- NCT03045419
- Acronym / sponsor ID
- SNUH-2009-5441
- Keywords
- MRI, gadoxetic acid, CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 29 Dec 2009 (actual)
- Primary completion
- 24 Nov 2013 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Feb 2017 (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.
It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC.
Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.
Detailed description
In terms of confirmative diagnosis, HCC is unique compared with other malignant tumors, as it can be diagnosed noninvasively based on its characteristic imaging features, that is, arterial hyperenhancement (washin) and hypoenhancement (washout) on portal or delayed phase at contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) using extracellular contrast media (ECCM). According to Liver Imaging Reporting and Data System (LI-RADS), hypointensity and isointensity on hepatobiliary phase (HBP) at gadoxetic acid-enhanced MRI are suggestive of malignancy and benignity, respectively, and those features are uniquely provided by only hepatocyte-specific contrast agent. However, these features are not included in diagnostic criteria because of its non-specificity, and indeed, gadoxetic acid-enhanced MRI is not yet included in AASLD and EASL guidelines as a diagnostic modality. If gadoxetic acid-enhanced MRI would provide better performance to diagnose HCC than CT, gadoxetic acid-enhanced MRI should be considered as a next step before biopsy in those small and/or atypical nodules to avoid potential diagnostic pitfall and morbidity, which is currently depending on physicians' decision. Thus, it would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC.
Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Procedure: gadoxetic acid-enhanced liver MRI* with small hepatic nodules (10-19mm) or atypical hepatic nodule (= or > 20mm) and high-risk group of HCC * scheduled for gadoxetic acid-enhanced liver MRI or liver nodule biopsy |
| Living liver donor candidates | – | Procedure: gadoxetic acid-enhanced liver MRI* living liver donor candidates without history of liver disease * schedule for gadoxetic acid-enhanced liver MRI as preoperative workup * only used for control of normal liver parenchymal enhancement on hepatobiliary phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients at a risk of HCC and had focal liver lesion at CT.
Key inclusion criteria (4 listed)
- patients with chronic hepatitis B or cirrhosis of any etiology
- signed informed consent AND
- being referred to radiology department for gadoxetic acid-enhanced MRI due to small nodule (10-19mm) at contrast-enhanced CT scan within 30 days as an radiofrequency ablation (RFA) work-up OR
- being referred to radiology department for percutaneous biopsy for atypical hepatic nodules (≥20mm) detected at contrast-enhanced CT within 30 days before biopsy
Key exclusion criteria (1 listed)
- Any contraindication for MRI and MR contrast agent
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 MRIliver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid | Procedure or surgery | Living liver donor candidates, Patients group |
Primary outcome
sensitivity to diagnose HCC, per-nodule base
Time frame: 12 months after MRI
sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base
3 secondary outcomes
specificity to diagnose HCC, per-nodule base
Time frame: 12 months after MRI
sensitivity to diagnose HCC, per-patient base
Time frame: 12 months after MRI
specificity to diagnose HCC, per-patient base
Time frame: 12 months 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 7 Feb 2017.
- 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?
An observational study of Hcc and Diagnosis, 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 4 inclusion and 1 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 7 Feb 2017. 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?
sensitivity to diagnose HCC, per-nodule base (time frame: 12 months 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 7 Feb 2017.