Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 11, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedFebruary 22, 2016
February 1, 2016
1.8 years
February 11, 2016
February 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Rate of tumor visibility on planning USG with/without fusion technique
10 minutes after finishing planning USG
Number of patients with safety access route on planning USG with/without fusion technique
10 minutes after finishing planning USG
Other Outcomes (1)
Anticipated number of overlapping of RFA electrodes on planning USG with/without fusion technique
30 minutes after finishing planning USG
Study Arms (1)
CT/US fusion
OTHERpatients 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.
Interventions
Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
Eligibility Criteria
You may qualify if:
- referred to Radiology in our institution for liver tumor RFA
- available pre-RFA liver CT or liver MR imaging within 6 weeks
You may not qualify if:
- any contraindication of liver RFA
- any patients who received treatment between pre-RFA imaging and planned RFA
- patients referred for palliative purpose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 27650284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 11, 2016
First Posted
February 22, 2016
Study Start
March 1, 2013
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
February 22, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share