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Completed

NCT Number: NCT02687113

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

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT/US fusion

Device

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

Primary outcomes

  1. RFA feasibility rates on planning USG with/without fusion CT/MR and US

    Time frame: 10 minutes after finishing planning USG

    comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG

Secondary outcomes

  1. Rate of tumor visibility on planning USG with/without fusion technique

    Time frame: 10 minutes after finishing planning USG

    comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG

  2. Number of patients with safety access route on planning USG with/without fusion technique

    Time frame: 10 minutes after finishing planning USG

    comparison of number of patients with presence/absence of safety access route, and the on two planning USGs

Other outcomes

  1. Anticipated number of overlapping of RFA electrodes on planning USG with/without fusion technique

    Time frame: 30 minutes after finishing planning USG

    comparison of anticipated number of electrode overlapping on two planning USGs

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 22, 2016
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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