An Intraoperative Guidance Platform for Radio Frequency Ablation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RFA Physics Library- PGP
The RFA Physics Library will be used during during percutaneous liver RFA procedures.
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Research software used to support liver RFA of HCC lesions >2cm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Technical Success of Tumor Ablation
Time Frame: Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
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Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.
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Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
|
|
Rate of Local Tumor Recurrence
Time Frame: 2 years after RFA treatment
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Local recurrence at 2 years is defined as the detection of viable malignant tissues at edge of or within a site which was previously treated by RFA.
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2 years after RFA treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric K Hoffer, MD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SF19108
- 2R44CA189515 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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