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Completed

NCT Number: NCT04844112

CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation

To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.

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Key information

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 automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologic or typical imaging based diagnosis of HCC
  • Multiphase CT or MRI within 3 months ahead of procedure
  • No evidence of distant metastasis
  • No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet > 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number >4, largest tumor size > 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.

Exclusion criteria

  • Lack of multiphase CT or MRI withing 3 months ahead of procedure
  • RFA planned for palliative purpose
  • Diagnosed as non-HCC malignancy
  • Right hepatectomy state

Treatment and study plan

automatic CT/MRI-US fusion system guided radiofrequency ablation

Procedure

automatic CT/MRI-US fusion system guided radiofrequency ablation

Primary outcomes

  1. Technical success rate of the fusion process

    Time frame: Immediately after fusion process

    Absolute technical success rate of the fusion process

  2. Technical success rate of the overall RFA procedure

    Time frame: immediately after RFA procedure

    Absolute technical success rate of the overall RFA compared to literature

  3. Rate of complete ablation of the tumor after 1 month clinical follow up

    Time frame: 1 month after the RFA procedure

    Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature

Secondary outcomes

  1. Local tumor progression rate

    Time frame: During post procedural follow up to 5 years

    Local tumor progression rate after follow up compared to literature

  2. Tumor visibility before and after the fusion process

    Time frame: 10 minutes after finishing planning USG

    Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.

  3. Technical feasibility before and after the fusion process

    Time frame: 10 minutes after finishing planning USG

    Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.

  4. Safety of the approach route before and after the fusion process

    Time frame: 10 minutes after finishing planning USG

    Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Philips Healthcare

Registry information

Official study title

Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2021
Registry last updated
Apr 14, 2021

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

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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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