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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
automatic CT/MRI-US fusion system guided radiofrequency ablation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Radiofrequency ablation, Fusion imaging

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental arm

    Arm Description

    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 automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.

    Outcomes

    Primary Outcome Measures

    Technical success rate of the fusion process
    Absolute technical success rate of the fusion process
    Technical success rate of the overall RFA procedure
    Absolute technical success rate of the overall RFA compared to literature
    Rate of complete ablation of the tumor after 1 month clinical follow up
    Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature

    Secondary Outcome Measures

    Local tumor progression rate
    Local tumor progression rate after follow up compared to literature
    Tumor visibility before and after the fusion process
    Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
    Technical feasibility before and after the fusion process
    Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
    Safety of the approach route before and after the fusion process
    Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.

    Full Information

    First Posted
    April 6, 2021
    Last Updated
    April 8, 2021
    Sponsor
    Seoul National University Hospital
    Collaborators
    Philips Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04844112
    Brief Title
    CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation
    Official Title
    Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    November 30, 2016 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Philips Healthcare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma
    Keywords
    Radiofrequency ablation, Fusion imaging

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    139 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental arm
    Arm Type
    Experimental
    Arm Description
    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 automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.
    Intervention Type
    Procedure
    Intervention Name(s)
    automatic CT/MRI-US fusion system guided radiofrequency ablation
    Intervention Description
    automatic CT/MRI-US fusion system guided radiofrequency ablation
    Primary Outcome Measure Information:
    Title
    Technical success rate of the fusion process
    Description
    Absolute technical success rate of the fusion process
    Time Frame
    Immediately after fusion process
    Title
    Technical success rate of the overall RFA procedure
    Description
    Absolute technical success rate of the overall RFA compared to literature
    Time Frame
    immediately after RFA procedure
    Title
    Rate of complete ablation of the tumor after 1 month clinical follow up
    Description
    Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature
    Time Frame
    1 month after the RFA procedure
    Secondary Outcome Measure Information:
    Title
    Local tumor progression rate
    Description
    Local tumor progression rate after follow up compared to literature
    Time Frame
    During post procedural follow up to 5 years
    Title
    Tumor visibility before and after the fusion process
    Description
    Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
    Time Frame
    10 minutes after finishing planning USG
    Title
    Technical feasibility before and after the fusion process
    Description
    Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
    Time Frame
    10 minutes after finishing planning USG
    Title
    Safety of the approach route before and after the fusion process
    Description
    Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
    Time Frame
    10 minutes after finishing planning USG

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeong Min Lee
    Organizational Affiliation
    Professor
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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