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

NCT ID: NCT04844112

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2016-11-30

Brief Summary

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.

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

automatic CT/MRI-US fusion system guided radiofrequency ablation

Intervention Type: PROCEDURE

automatic CT/MRI-US fusion system guided radiofrequency ablation

Interventions

automatic CT/MRI-US fusion system guided radiofrequency ablation

automatic CT/MRI-US fusion system guided radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee

Role: STUDY_CHAIR

Professor

Other Identifiers

1506-015-677

Identifier Type: -

Identifier Source: org_study_id