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

Seoul National University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04844112

1506-015-677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation