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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844112
• Other study ID #: 1506-015-677
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: April 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Philips Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success rate of the fusion process	Absolute technical success rate of the fusion process	Immediately after fusion process
Primary	Technical success rate of the overall RFA procedure	Absolute technical success rate of the overall RFA compared to literature	immediately after RFA procedure
Primary	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	Local tumor progression rate	Local tumor progression rate after follow up compared to literature	During post procedural follow up to 5 years
Secondary	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
Secondary	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
Secondary	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