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Completed

NCT Number: NCT02967198

Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging

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).

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Key information

Age range

20 year and older

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. 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).

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 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.

Treatment and study plan

CT/US fusion

Device

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

ultrasound shear wave elastography

Device

ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Other names: S-shear wave

Primary outcomes

  1. RFA or biopsy 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

  2. Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)

    Time frame: 10 minutes after finishing planning USG

    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 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2016
Registry last updated
Nov 18, 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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