Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion

Pre-procedure Planning for Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans: Preliminary Study

The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone.

Study Overview

• Status: Completed
• Conditions: Liver Cancer
• Intervention / Treatment: Device: CT/US fusion

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

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: all conditions should be satisfied for inclusion.

• referred to Radiology in our institution for liver tumor RFA
• available pre-RFA liver CT or liver MR imaging within 6 weeks

Exclusion Criteria: patients with any of following condition should be excluded.

• any contraindication of liver RFA
• any patients who received treatment between pre-RFA imaging and planned RFA
• patients referred for palliative purpose.

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
Other: CT/US fusion; 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 CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.	Device: CT/US fusion; Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RFA feasibility rates on planning USG with/without fusion CT/MR and US	comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG	10 minutes after finishing planning USG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tumor visibility on planning USG with/without fusion technique	comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG	10 minutes after finishing planning USG
Number of patients with safety access route on planning USG with/without fusion technique	comparison of number of patients with presence/absence of safety access route, and the on two planning USGs	10 minutes after finishing planning USG

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticipated number of overlapping of RFA electrodes on planning USG with/without fusion technique	comparison of anticipated number of electrode overlapping on two planning USGs	30 minutes after finishing planning USG

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Ahn SJ, Lee JM, Lee DH, Lee SM, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Real-time US-CT/MR fusion imaging for percutaneous radiofrequency ablation of hepatocellular carcinoma. J Hepatol. 2017 Feb;66(2):347-354. doi: 10.1016/j.jhep.2016.09.003. Epub 2016 Sep 17.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 19, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: ablation; fusion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2012-2361

Plan for Individual participant data (IPD)

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