An Intraoperative Guidance Platform for Radio Frequency Ablation
NCT ID: NCT04152343
Last Updated: 2024-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2019-12-07
2023-03-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RFA Physics Library- PGP
The RFA Physics Library will be used during during percutaneous liver RFA procedures.
RFA Physics Library -- a Planning and Guidance Platform (PGP)
Research software used to support liver RFA of HCC lesions \>2cm
Interventions
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RFA Physics Library -- a Planning and Guidance Platform (PGP)
Research software used to support liver RFA of HCC lesions \>2cm
Eligibility Criteria
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Inclusion Criteria
2. Presence of hepatocellular carcinoma with a size equal or larger than 2cm.
3. Scheduled for CT-guided thermal ablation under General Anesthesia
4. Able to provide written, informed consent
Exclusion Criteria
1. the presence of an electronic implant, such as a pacemaker not approved for MRI
2. the presence of a metal implant, such as an aneurysm clip not approved for MRI
3. claustrophobia
4. the presence of other contraindication(s), such as inability to comfortably lie flat, history of working with metal, other implanted hardware or shrapnel
2. Target tumor adjacent to or within prior ablated or resected site.
3. Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Eric K. Hoffer
Director, Vascular and Interventional Radiology
Principal Investigators
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Eric K Hoffer, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SF19108
Identifier Type: -
Identifier Source: org_study_id
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