CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation

Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study

To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation

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 automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologic or typical imaging based diagnosis of HCC
• Multiphase CT or MRI within 3 months ahead of procedure
• No evidence of distant metastasis
• No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet > 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number >4, largest tumor size > 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.

Exclusion Criteria:

• Lack of multiphase CT or MRI withing 3 months ahead of procedure
• RFA planned for palliative purpose
• Diagnosed as non-HCC malignancy
• Right hepatectomy state

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; 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 automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.	Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation; automatic CT/MRI-US fusion system guided radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate of the fusion process	Absolute technical success rate of the fusion process	Immediately after fusion process
Technical success rate of the overall RFA procedure	Absolute technical success rate of the overall RFA compared to literature	immediately after RFA procedure
Rate of complete ablation of the tumor after 1 month clinical follow up	Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature	1 month after the RFA procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor progression rate	Local tumor progression rate after follow up compared to literature	During post procedural follow up to 5 years
Tumor visibility before and after the fusion process	Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.	10 minutes after finishing planning USG
Technical feasibility before and after the fusion process	Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.	10 minutes after finishing planning USG
Safety of the approach route before and after the fusion process	Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.	10 minutes after finishing planning USG

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Philips Healthcare
• Investigators: Study Chair: Jeong Min Lee, Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Radiofrequency ablation; Fusion imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: 1506-015-677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No