Liver CancerNCT02687113
Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion
A study testing CT/US fusion in people with Liver Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cancer
- What is being tested?
- CT/US fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Mar 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: all conditions should be satisfied for inclusion.
- referred to Radiology in our institution for liver tumor RFA
- available pre-RFA liver CT or liver MR imaging within 6 weeks
Exclusion Criteria: patients with any of following condition should be excluded.
- any contraindication of liver RFA
- any patients who received treatment between pre-RFA imaging and planned RFA
- patients referred for palliative purpose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-procedure Planning for Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans: Preliminary Study
The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone.
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 US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors in comparison with conventional US alone technique.
- Conditions
- Liver Cancer
- Being tested
- CT/US fusion
- Keywords
- ablation, fusion
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT/US fusionDevice
Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
| Study group | Role | What they receive |
|---|---|---|
| CT/US fusion | Other | 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 CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. Receives: Device: CT/US fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFA feasibility rates on planning USG with/without fusion CT/MR and US
comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG
Measured: 10 minutes after finishing planning USG
Secondary outcomes (2)
Rate of tumor visibility on planning USG with/without fusion technique
comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG
Measured: 10 minutes after finishing planning USG
Number of patients with safety access route on planning USG with/without fusion technique
comparison of number of patients with presence/absence of safety access route, and the on two planning USGs
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 posted22 Feb 2016 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies 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
- 240 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
- NCT02687113
- Sponsor's protocol ID
- 2012-2361
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ahn SJ, Lee JM, Lee DH, Lee SM, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Real-time US-CT/MR fusion imaging for percutaneous radiofrequency ablation of hepatocellular carcinoma. J Hepatol. 2017 Feb;66(2):347-354. doi: 10.1016/j.jhep.2016.09.003. Epub 2016 Sep 17.
PubMed 27650284
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-procedure Planning for Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans: Preliminary Study
- ClinicalTrials.gov ID
- NCT02687113
- Acronym / sponsor ID
- 2012-2361
- Conditions
- Liver Cancer
- Keywords
- ablation, fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Feb 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.
The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone.
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 US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors in comparison with conventional US alone technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT/US fusion | Other | Device: CT/US fusionpatients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CT/US fusionFusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device. | Device | CT/US fusion |
Primary outcome
RFA feasibility rates on planning USG with/without fusion CT/MR and US
Time frame: 10 minutes after finishing planning USG
comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG
2 secondary outcomes
Rate of tumor visibility on planning USG with/without fusion technique
Time frame: 10 minutes after finishing planning USG
Number of patients with safety access route on planning USG with/without fusion technique
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 22 Feb 2016.
- Derived from this study: PubMed 27650284Ahn SJ, Lee JM, Lee DH, Lee SM, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Real-time US-CT/MR fusion imaging for percutaneous radiofrequency ablation of hepatocellular carcinoma. J Hepatol. 2017 Feb;66(2):347-354. doi: 10.1016/j.jhep.2016.09.003. Epub 2016 Sep 17.
- 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 study testing CT/US fusion in people with Liver Cancer, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 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?
RFA feasibility rates on planning USG with/without fusion CT/MR and US (time frame: 10 minutes after finishing planning USG). 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 NCT02687113, which also lists 1 linked publication.
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 22 Feb 2016.