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

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ClinicalTrials.gov Identifier: NCT04844112
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental arm

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.

 Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation
automatic CT/MRI-US fusion system guided radiofrequency ablation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844112


Sponsors and Collaborators
Seoul National University Hospital
Philips Healthcare
Investigators
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Study Chair: Jeong Min Lee Professor
More Information
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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04844112    
Other Study ID Numbers: 1506-015-677
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
Radiofrequency ablation
Fusion imaging
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases