Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma

JOON-IL CHOI82 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul St.Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Registration accuracy

Accuracy of imaging fusion (US and MRI)

Time frame: Immediately after RF ablation

Secondary Outcomes

Technical success

Completeness of tumor ablation

Time frame: Within 48 hours after RF ablation

Technical effectiveness

Completeness of tumor ablation

Time frame: One month after RF ablation

Registration time

Time required for registration

Time frame: Within 48 hours after RF ablation

Data from ClinicalTrials.gov

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