Clinical trial NCT02687113: Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion
Official title: Pre-procedure Planning for Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans: Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: ablation
fusion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: RFA feasibility rates on planning USG with/without fusion CT/MR and US
timeFrame: 10 minutes after finishing planning USG
Secondary outcomes:
measure: Rate of tumor visibility on planning USG with/without fusion technique
timeFrame: 10 minutes after finishing planning USG
measure: Number of patients with safety access route on planning USG with/without fusion technique
timeFrame: 10 minutes after finishing planning USG
Other outcomes:
measure: Anticipated number of overlapping of RFA electrodes on planning USG with/without fusion technique
timeFrame: 30 minutes after finishing planning USG
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.