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

Seoul National University Hospital139 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Hepatocellular Carcinoma

Interventions

automatic CT/MRI-US fusion system guided radiofrequency ablationPROCEDURE

automatic CT/MRI-US fusion system guided radiofrequency ablation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Technical success rate of the fusion process

Absolute technical success rate of the fusion process

Time frame: Immediately after fusion process

Technical success rate of the overall RFA procedure

Absolute technical success rate of the overall RFA compared to literature

Time frame: 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

Time frame: 1 month after the RFA procedure

Secondary Outcomes

Local tumor progression rate

Local tumor progression rate after follow up compared to literature

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 10 minutes after finishing planning USG

Data from ClinicalTrials.gov

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