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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687113
• Other study ID #: 2012-2361
• Status: Completed
• Phase: N/A
• First received: February 11, 2016
• Last updated: February 19, 2016
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer

Intervention

Device:
• CT/US fusion
Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No