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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Manual Imaging fusion of ultrasonography and MRI; Device: Automatic Imaging fusion of ultrasonography and MRI

• Registration Number: NCT02705118
• Lead Sponsor: JOON-IL CHOI

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2016-03-05
• Study First Posted: 2016-03-10
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual registration arm	Manual Imaging fusion of ultrasonography and MRI	Manual registration for fusion imaging of US and MRI will be performed. Manual Imaging fusion of ultrasonography and MRI
Automatic registration arm	Automatic Imaging fusion of ultrasonography and MRI	Automatic registration for fusion imaging of US and MRI will be performed. Automatic Imaging fusion of ultrasonography and MRI

Primary Outcome Measures

Name	Time	Method
Registration accuracy	Immediately after RF ablation	Accuracy of imaging fusion (US and MRI)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of