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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT/US fusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring ablation, fusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CT/US fusion

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 11, 2016
Last Updated
February 19, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02687113
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
ablation, fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT/US fusion
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CT/US fusion
Intervention Description
Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
Primary Outcome Measure Information:
Title
RFA feasibility rates on planning USG with/without fusion CT/MR and US
Description
comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG
Time Frame
10 minutes after finishing planning USG
Secondary Outcome Measure Information:
Title
Rate of tumor visibility on planning USG with/without fusion technique
Description
comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG
Time Frame
10 minutes after finishing planning USG
Title
Number of patients with safety access route on planning USG with/without fusion technique
Description
comparison of number of patients with presence/absence of safety access route, and the on two planning USGs
Time Frame
10 minutes after finishing planning USG
Other Pre-specified Outcome Measures:
Title
Anticipated number of overlapping of RFA electrodes on planning USG with/without fusion technique
Description
comparison of anticipated number of electrode overlapping on two planning USGs
Time Frame
30 minutes after finishing planning USG

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27650284
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.
Results Reference
derived

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

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