Hepatocellular CarcinomaFAME-USNCT02705118
Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma
A study testing Automatic Imaging fusion of ultrasonography and MRI and Manual Imaging fusion of ultrasonography and MRI in people with Hepatocellular Carcinoma, run by JOON-IL CHOI at 1 site in South Korea.
Trial summary
Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Automatic Imaging fusion of ultrasonography and MRI and Manual Imaging fusion of ultrasonography and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to 31 Mar 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 40-years old
- Patients with hepatic malignancy who will underwent radiofrequency ablation
Who cannot join
- Not using fusion imaging (CT guidance or fluoroscopic guidance)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study
Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.
Read the detailed description
- Patients will be randomized and assigned.
- For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
- For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.
- After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.
- After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Automatic Imaging fusion of ultrasonography and MRI, Manual Imaging fusion of ultrasonography and MRI
- Keywords
- radiofrequency ablation, image fusion
- 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 Imaging fusion of ultrasonography and MRIDevice
Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.
Manual Imaging fusion of ultrasonography and MRIDevice
Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.
| Study group | Role | What they receive |
|---|---|---|
| Automatic registration arm | Experimental | Automatic registration for fusion imaging of US and MRI will be performed.
Automatic Imaging fusion of ultrasonography and MRI Receives: Device: Automatic Imaging fusion of ultrasonography and MRI |
| Manual registration arm | Active comparator | Manual registration for fusion imaging of US and MRI will be performed.
Manual Imaging fusion of ultrasonography and MRI Receives: Device: Manual Imaging fusion of ultrasonography and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration accuracy
Accuracy of imaging fusion (US and MRI)
Measured: Immediately after RF ablation
Secondary outcomes (3)
Technical success
Completeness of tumor ablation
Measured: Within 48 hours after RF ablation
Technical effectiveness
Completeness of tumor ablation
Measured: One month after RF ablation
Registration time
Time required for registration
Measured: Within 48 hours after RF ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startDec 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOON-IL CHOI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JOON-IL CHOI, Seoul St. Mary's Hospital
- Investigators
- Joon-Il Choi, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705118
- Sponsor's protocol ID
- KC15DNSI0039
- Acronym
- FAME-US
- Status last verified
- May 2017
- First submitted
- 15 Dec 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT02705118
- Acronym / sponsor ID
- FAME-US / KC15DNSI0039
- Conditions
- Hepatocellular Carcinoma
- Keywords
- radiofrequency ablation, image fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- JOON-IL CHOIUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 10 Mar 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.
Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.
Detailed description
- Patients will be randomized and assigned.
- For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
- For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.
- After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.
- After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic registration arm | Experimental | Device: Automatic Imaging fusion of ultrasonography and MRIAutomatic registration for fusion imaging of US and MRI will be performed. Automatic Imaging fusion of ultrasonography and MRI |
| Manual registration arm | Active comparator | Device: Manual Imaging fusion of ultrasonography and MRIManual registration for fusion imaging of US and MRI will be performed. Manual Imaging fusion of ultrasonography and MRI |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 40-years old
- Patients with hepatic malignancy who will underwent radiofrequency ablation
Key exclusion criteria (1 listed)
- Not using fusion imaging (CT guidance or fluoroscopic guidance)
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 Imaging fusion of ultrasonography and MRIRadiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same. | Device | Automatic registration arm |
| Manual Imaging fusion of ultrasonography and MRIRadiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same. | Device | Manual registration arm |
Primary outcome
Registration accuracy
Time frame: Immediately after RF ablation
Accuracy of imaging fusion (US and MRI)
3 secondary outcomes
Technical success
Time frame: Within 48 hours after RF ablation
Technical effectiveness
Time frame: One month after RF ablation
Registration time
Time frame: Within 48 hours after RF ablation
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 25 May 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.
Joon-Il Choi principal investigator
Seoul St. Mary's 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 Automatic Imaging fusion of ultrasonography and MRI and Manual Imaging fusion of ultrasonography and MRI in people with Hepatocellular Carcinoma, run by JOON-IL CHOI 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 2 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 25 May 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?
Registration accuracy (time frame: Immediately after RF ablation). 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 25 May 2017.