Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging
Primary Purpose
Liver Mass, Liver Fibroses
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT/US fusion
ultrasound shear wave elastography
Sponsored by
About this trial
This is an interventional treatment trial for Liver Mass focused on measuring Fusion, Ablation, Percutaneous biopsy, Shear wave elastography
Eligibility Criteria
Inclusion Criteria:
all conditions should be satisfied for inclusion.
- referred to Radiology in our institution for liver tumor RFA or percutaneous liver biopsy
- available pre-procedure liver CT or liver MR imaging within 6 weeks
Exclusion Criteria:
- any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT/US fusion
Arm Description
patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or 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 or biopsy 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
Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)
To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
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
NCT ID
NCT02967198
First Posted
November 16, 2016
Last Updated
November 16, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02967198
Brief Title
Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging
Official Title
Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
Detailed Description
RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy.
For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure 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 or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique.
In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Mass, Liver Fibroses
Keywords
Fusion, Ablation, Percutaneous biopsy, Shear wave elastography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT/US fusion
Arm Type
Experimental
Arm Description
patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or 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-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
Intervention Type
Device
Intervention Name(s)
ultrasound shear wave elastography
Other Intervention Name(s)
S-shear wave
Intervention Description
ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.
Primary Outcome Measure Information:
Title
RFA or biopsy 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
Title
Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)
Description
To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
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 or percutaneous liver biopsy
available pre-procedure liver CT or liver MR imaging within 6 weeks
Exclusion Criteria:
any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging
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