An Intraoperative Guidance Platform for Radio Frequency Ablation

Study Overview
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Brief Summary
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This study tests the hypothesis that use of the research RFA (Radiofrequency ablation) Physics Library will result in more frequent technical success (complete necrotization of target tissues) compared to ablations conducted without computer guidance. The RFA Physics Library -- a Planning and Guidance Platform (PGP) (NE Scientific, LLC) -- will be used to support percutaneous liver RFA under CT-guidance by assisting physicians in the identification of ablation targets, assessment of proper ablation probe placement, and projection of the created ablation zones on the CT image.

Detailed Description
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Patients referred for curative ablation of an HCC by consensus recommendation of the multidisciplinary Liver Tumor Clinic at a 400-bed academic cancer center from June 2018 through December 2021 were considered for participation in the study. Inclusion criteria : patient : over 18 years old , ble to provide informed consent, expected survival >1 year lesion: HCC, >2 cm in diameter, located > 1 cm from any other lesion. procedure : completed using the support of the Accublate simulation software. Software detail at : Hoffer EK, Borsic A, Patel SD. Validation of Software for Patient-Specific Real-Time Simulation of Hepatic Radiofrequency Ablation. Acad Radiol. 2022 Oct;29(10):e219-e227. doi: 10.1016/j.acra.2021.12.018. PMID: 35039220; PMCID: PMC9276838 Treatment: CT-guided RFA with Boston Scientific LeVeen system, RF3000 Generator. . Prophylactic antibiotic General anesthesia; imaging during suspended ventilation, no PEEP Ablation per manufacturer's protocol. Target : tumor + 5 mm margin Planning, targeting, intraprocedural repositioning, assessment of ablation coverage using software simulation in conjunction with manufacturer's data map. Tract ablation Follow-up clinic visit with contrast-enhanced cross-sectional imaging (MRI or CT) at 3 months, then every 3 months x 2 years. Data review for complications, progression of liver disease, evidence of local, regional, or metastatic disease, and additional interventions. Outcome measures: primary : local tumor progression secondary: hepatic tumor progression

Official Title
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An Intraoperative Guidance Platform for Radio Frequency Ablation

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: RFA Physics Library -- a Planning and Guidance Platform (PGP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Presence of hepatocellular carcinoma with a size equal or larger than 2cm. Scheduled for CT-guided thermal ablation under General Anesthesia Able to provide written, informed consent Exclusion Criteria: Absolute of relative contraindication to MRI: the presence of an electronic implant, such as a pacemaker not approved for MRI the presence of a metal implant, such as an aneurysm clip not approved for MRI claustrophobia the presence of other contraindication(s), such as inability to comfortably lie flat, history of working with metal, other implanted hardware or shrapnel Target tumor adjacent to or within prior ablated or resected site. Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA Physics Library- PGP<br>The RFA Physics Library will be used during during percutaneous liver RFA procedures. | Device: RFA Physics Library -- a Planning and Guidance Platform (PGP)<br>* Research software used to support liver RFA of HCC lesions >2cm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Technical Success | Technical success is defined as the complete ablation of the target lesion (tumor and 3mm margin). | 2 years post RFA treatment | 
| Rate of Local Occurrence | Local recurrence is defined as the detection of viable malignant tissues at a site which was previously treated by RFA. | 2 years post RFA treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency Ablation