Hepatocellular CarcinomaNCT04844112
CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation
A study testing automatic CT/MRI-US fusion system guided radiofrequency ablation in people with Hepatocellular Carcinoma, run by Seoul National University Hospital.
Trial summary
To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- automatic CT/MRI-US fusion system guided radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 30 Nov 2016
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic or typical imaging based diagnosis of HCC
- Multiphase CT or MRI within 3 months ahead of procedure
- No evidence of distant metastasis
- No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet > 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number >4, largest tumor size > 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.
Who cannot join
- Lack of multiphase CT or MRI withing 3 months ahead of procedure
- RFA planned for palliative purpose
- Diagnosed as non-HCC malignancy
- Right hepatectomy state
About this study
Official title: Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study
To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.
Read the detailed description
RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- automatic CT/MRI-US fusion system guided radiofrequency ablation
- Keywords
- Radiofrequency ablation, Fusion imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic CT/MRI-US fusion system guided radiofrequency ablationProcedure or surgery
automatic CT/MRI-US fusion system guided radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | patients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound.
Then additional planning ultrasound using automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. Receives: Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate of the fusion process
Absolute technical success rate of the fusion process
Measured: Immediately after fusion process
Technical success rate of the overall RFA procedure
Absolute technical success rate of the overall RFA compared to literature
Measured: immediately after RFA procedure
Rate of complete ablation of the tumor after 1 month clinical follow up
Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature
Measured: 1 month after the RFA procedure
Secondary outcomes (4)
Local tumor progression rate
Local tumor progression rate after follow up compared to literature
Measured: During post procedural follow up to 5 years
Tumor visibility before and after the fusion process
Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
Measured: 10 minutes after finishing planning USG
Technical feasibility before and after the fusion process
Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
Measured: 10 minutes after finishing planning USG
Safety of the approach route before and after the fusion process
Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
Measured: 10 minutes after finishing planning USG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Aug 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844112
- Sponsor's protocol ID
- 1506-015-677
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study
- ClinicalTrials.gov ID
- NCT04844112
- Acronym / sponsor ID
- 1506-015-677
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Radiofrequency ablation, Fusion imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 14 Apr 2021 (actual)
- 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.
To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.
Detailed description
RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablationpatients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologic or typical imaging based diagnosis of HCC
- Multiphase CT or MRI within 3 months ahead of procedure
- No evidence of distant metastasis
- No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet > 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number >4, largest tumor size > 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.
Key exclusion criteria (4 listed)
- Lack of multiphase CT or MRI withing 3 months ahead of procedure
- RFA planned for palliative purpose
- Diagnosed as non-HCC malignancy
- Right hepatectomy state
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 |
|---|---|---|
| automatic CT/MRI-US fusion system guided radiofrequency ablationautomatic CT/MRI-US fusion system guided radiofrequency ablation | Procedure or surgery | Experimental arm |
Primary outcome
Technical success rate of the fusion process
Time frame: Immediately after fusion process
Absolute technical success rate of the fusion process
Technical success rate of the overall RFA procedure
Time frame: immediately after RFA procedure
Absolute technical success rate of the overall RFA compared to literature
Rate of complete ablation of the tumor after 1 month clinical follow up
Time frame: 1 month after the RFA procedure
Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature
4 secondary outcomes
Local tumor progression rate
Time frame: During post procedural follow up to 5 years
Tumor visibility before and after the fusion process
Time frame: 10 minutes after finishing planning USG
Technical feasibility before and after the fusion process
Time frame: 10 minutes after finishing planning USG
Safety of the approach route before and after the fusion process
Time frame: 10 minutes after finishing planning USG
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 14 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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 study chair
Professor
Questions about this trial
What is this clinical trial studying?
A study testing automatic CT/MRI-US fusion system guided radiofrequency ablation in people with Hepatocellular Carcinoma, run by Seoul National University Hospital.
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 4 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Technical success rate of the fusion process (time frame: Immediately after fusion process). The study lists 3 primary outcomes in all. 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 14 Apr 2021.