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

NCT ID: NCT02687113

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Liver Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT/US fusion

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.

Group Type OTHER

CT/US fusion

Intervention Type DEVICE

Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

Interventions

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CT/US fusion

Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* referred to Radiology in our institution for liver tumor RFA
* available pre-RFA liver CT or liver MR imaging within 6 weeks

Exclusion Criteria

* any contraindication of liver RFA
* any patients who received treatment between pre-RFA imaging and planned RFA
* patients referred for palliative purpose.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 27650284 (View on PubMed)

Other Identifiers

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2012-2361

Identifier Type: -

Identifier Source: org_study_id

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