HCCNCT02985034
Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT
An observational study of HCC and Liver Tumor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC, Liver Tumor
- What is being tested?
- RFA
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver tumor and referred to Radiology for RFA.
Who may be able to join
- patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA
- patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA
- patients with 1-3 tumors (<5 cm)
Who cannot join
- Child-Pugh class C
- any uncorrected coagulopathy
- hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration
Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.
- Conditions
- HCC, Liver Tumor
- Being tested
- RFA
- Keywords
- HCC, RFA, Liver tumor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
Radiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression (LTP)
5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)
Measured: 60 months
Secondary outcomes (3)
technique efficacy
Rate of absence of viable tumor on 1-months follow-up CT scan.
Measured: 1 month after RFA
immediate technical success on visual assessment
technical success of RFA on post-RFA CT using side-by-side comparison of pre-RFA MRI and post-RFA CT
Measured: 1 day after RFA
immediate technical success on registration-software assessment
technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT
Measured: 1 day after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionOct 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT02985034
- Sponsor's protocol ID
- SNUH-2010-1412
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 7 Dec 2016
- 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 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration
- ClinicalTrials.gov ID
- NCT02985034
- Acronym / sponsor ID
- SNUH-2010-1412
- Conditions
- HCC, Liver Tumor
- Keywords
- HCC, RFA, Liver tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Dec 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.
Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver tumor and referred to Radiology for RFA.
Key inclusion criteria (3 listed)
- patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA
- patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA
- patients with 1-3 tumors (<5 cm)
Key exclusion criteria (3 listed)
- Child-Pugh class C
- any uncorrected coagulopathy
- hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT
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 |
|---|---|---|
| RFARadiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities. | Procedure or surgery | – |
Primary outcome
Local tumor progression (LTP)
Time frame: 60 months
5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)
3 secondary outcomes
technique efficacy
Time frame: 1 month after RFA
immediate technical success on visual assessment
Time frame: 1 day after RFA
immediate technical success on registration-software assessment
Time frame: 1 day 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 7 Dec 2016.
- 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 Liver Tumor, 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 3 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 Dec 2016. 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?
Local tumor progression (LTP) (time frame: 60 months). 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 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.