Hepatocellular Carcinoma
Conditions
Keywords
radiofrequency ablation, image fusion
Brief 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. 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
1. Patients will be randomized and assigned. 2. 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. 3. 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. 3\) 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. 5\) 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.
Interventions
DEVICEAutomatic Imaging fusion of ultrasonography and MRI
Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.
DEVICEManual Imaging fusion of ultrasonography and MRI
Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.
Sponsors
JOON-IL CHOI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* More than 40-years old * Patients with hepatic malignancy who will underwent radiofrequency ablation
Exclusion criteria
* Not using fusion imaging (CT guidance or fluoroscopic guidance)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Registration accuracy | Immediately after RF ablation | Accuracy of imaging fusion (US and MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Within 48 hours after RF ablation | Completeness of tumor ablation |
| Technical effectiveness | One month after RF ablation | Completeness of tumor ablation |
| Registration time | Within 48 hours after RF ablation | Time required for registration |
Countries
South Korea
Outcome results
None listed