Added Value of Contrast-enhanced Ultrasonography for Percutaneous Radiofrequency Ablation

NCT ID: NCT05445973

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-30

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.

Conditions

Radiofrequency Ablation; Ultrasonography; Liver Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Percutaneous Radiofrequency Ablation

Intervention Type: PROCEDURE

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.

Interventions

Percutaneous Radiofrequency Ablation

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Countries

South Korea

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Other Identifiers

SUNH 1811-136-989

Identifier Type: -

Identifier Source: org_study_id