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Added Value of Contrast-enhanced Ultrasonography for Percutaneous Radiofrequency Ablation

Primary Purpose

Radiofrequency Ablation, Ultrasonography, Liver Tumors

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous 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 Radiofrequency Ablation focused on measuring Percutaneous Radiofrequency Ablation, Real-Time Contrast-Enhanced Ultrasonography, Small Liver Tumors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • inconspicuous or invisible index tumors for ablation on US
  • tumor size ≤ 3 cm
  • pathologic diagnosis of primary or secondary liver malignancy or imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines or viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm
  • consideration of curative-intent RFA

Exclusion Criteria:

  • well-visible tumors (visibility score of 3 or 4) on the planning B-mode US
  • the absence of available data from multiphase CT or MRI performed in the 3-month pre-procedure period
  • poor quality registration of US-CT/MRI fusion imaging and RFA planned with palliative intent
  • contraindications for the conventional RFA procedure at the authors' institution, which are uncontrollable coagulopathy (platelet count < 50,000/μL or international standard ratio ≥ 1.6), a low level of cooperation, impracticality of sedation, portal vein thrombus, the tumor abutting the portal vein, or larger bile ducts than the segmental branches

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance

Arm Description

To investigate whether CEUS-CT/MRI fusion imaging improved the visualization of small (≤ 3 cm) primary and secondary malignant liver tumors that were inconspicuous on B-mode US for percutaneous RFA.

Outcomes

Primary Outcome Measures

Local tumor progression rate
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI)

Secondary Outcome Measures

Technical success rate of radiofrequency ablation using contrast-enhanced US-CT/MRI fusion image
The technical success of radiofrequency ablation is defined as complete ablation of tumor with safety margin and evaluated by immediate post-procedural computed tomography.

Full Information

First Posted
June 17, 2022
Last Updated
June 30, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05445973
Brief Title
Added Value of Contrast-enhanced Ultrasonography for Percutaneous Radiofrequency Ablation
Official Title
Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance for Percutaneous Radiofrequency Ablation of Inconspicuous, Small Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Contrast-enhanced ultrasonography (CEUS)-CT/MRI fusion imaging substantially improved the visibility of small tumors that were inconspicuous on both US and US-CT/MRI fusion imaging, contributing to successful percutaneous radiofrequency ablation.
Detailed Description
Percutaneous radiofrequency ablation (RFA) has been widely implemented as a curative treatment for liver malignancies. The overall survival post-RFA is comparable to that of surgical outcomes for small hepatocellular carcinomas (HCCs) (≤ 3 cm). US guidance for RFA is common in Asia because the real-time capability of US allows precise electrode placement. However, precisely targeting small liver malignancies with poor sonographic conspicuity in US-guided RFA is often challenging. To solve this problem, CEUS or real-time fusion imaging (FI) of US and CT/MRI have been used. Both approaches have been reported to improve the confidence for tumor localization in RFA for small HCCs with poor B-mode US visibility. However, when an index tumor is entirely invisible on B-mode US, neither method is ideal, especially for multiple-electrode RFA, due to inherent registration errors on FI or insonation-induced bubble destruction on CEUS with SonoVue. Therefore, there is a clinical need to compensate for the inherent registration errors of US-CT/MRI FI for inconspicuous tumors on both US and US-CT/MRI FI. Recent studies reported that after adding CEUS using Sonazoid (GE Healthcare, Waukesha, WI, USA) or SonoVue to FI, 83.3% to 90% of target liver cancers that were initially difficult to visualize on FI became conspicuous, allowing them to be directly targeted for RFA. However, these studies had limitations, including a retrospective study design, a small sample size (< 30 inconspicuous tumors), or a short-term follow-up (< 1 year). Furthermore, no prospective study has explored the value of CEUS-CT/MRI FI, using both SonoVue and Sonazoid as contrast agents, for localizing index tumors and guiding RFA procedures in patients with inconspicuous tumors on B-mode US and reported its therapeutic impact on local tumor control. Therefore, the present study investigated whether CEUS-CT/MRI FI improved the visibility of small (≤ 3 cm) primary and secondary liver tumors that were invisible or difficult to visualize on B-mode US for percutaneous RFA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiofrequency Ablation, Ultrasonography, Liver Tumors
Keywords
Percutaneous Radiofrequency Ablation, Real-Time Contrast-Enhanced Ultrasonography, Small Liver Tumors

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance
Arm Type
Experimental
Arm Description
To investigate whether CEUS-CT/MRI fusion imaging improved the visualization of small (≤ 3 cm) primary and secondary malignant liver tumors that were inconspicuous on B-mode US for percutaneous RFA.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Radiofrequency Ablation
Intervention Description
In brief, ablation was performed using a 200-W multichannel generator and a switching monopolar technique with separate clustered electrodes. Tumor targeting was done under the guidance of CEUS-CT/MRI FI, and the ablation procedure was monitored with US-FI. The ablation procedure was terminated when the operator expected to complete the ablation of the index tumor with a minimum 5-mm ablative margin on the US-FI images.
Primary Outcome Measure Information:
Title
Local tumor progression rate
Description
Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI)
Time Frame
12 months after the radiofrequency ablation
Secondary Outcome Measure Information:
Title
Technical success rate of radiofrequency ablation using contrast-enhanced US-CT/MRI fusion image
Description
The technical success of radiofrequency ablation is defined as complete ablation of tumor with safety margin and evaluated by immediate post-procedural computed tomography.
Time Frame
Immediately after radiofrequency ablation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: inconspicuous or invisible index tumors for ablation on US tumor size ≤ 3 cm pathologic diagnosis of primary or secondary liver malignancy or imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines or viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm consideration of curative-intent RFA Exclusion Criteria: well-visible tumors (visibility score of 3 or 4) on the planning B-mode US the absence of available data from multiphase CT or MRI performed in the 3-month pre-procedure period poor quality registration of US-CT/MRI fusion imaging and RFA planned with palliative intent contraindications for the conventional RFA procedure at the authors' institution, which are uncontrollable coagulopathy (platelet count < 50,000/μL or international standard ratio ≥ 1.6), a low level of cooperation, impracticality of sedation, portal vein thrombus, the tumor abutting the portal vein, or larger bile ducts than the segmental branches
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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29962861
Citation
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Added Value of Contrast-enhanced Ultrasonography for Percutaneous Radiofrequency Ablation

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