An Intraoperative Guidance Platform for Radio Frequency Ablation
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RFA Physics Library -- a Planning and Guidance Platform (PGP)
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Radiofrequency Ablation
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RFA Physics Library- PGP
Arm Description
The RFA Physics Library will be used during during percutaneous liver RFA procedures.
Outcomes
Primary Outcome Measures
Rate of Technical Success
Technical success is defined as the complete ablation of the target lesion (tumor and 3mm margin).
Rate of Local Occurrence
Local recurrence is defined as the detection of viable malignant tissues at a site which was previously treated by RFA.
Secondary Outcome Measures
Full Information
NCT ID
NCT04152343
First Posted
November 2, 2019
Last Updated
April 15, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04152343
Brief Title
An Intraoperative Guidance Platform for Radio Frequency Ablation
Official Title
An Intraoperative Guidance Platform for Radio Frequency Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 7, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Radiofrequency Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA Physics Library- PGP
Arm Type
Experimental
Arm Description
The RFA Physics Library will be used during during percutaneous liver RFA procedures.
Intervention Type
Device
Intervention Name(s)
RFA Physics Library -- a Planning and Guidance Platform (PGP)
Intervention Description
Research software used to support liver RFA of HCC lesions >2cm
Primary Outcome Measure Information:
Title
Rate of Technical Success
Description
Technical success is defined as the complete ablation of the target lesion (tumor and 3mm margin).
Time Frame
2 years post RFA treatment
Title
Rate of Local Occurrence
Description
Local recurrence is defined as the detection of viable malignant tissues at a site which was previously treated by RFA.
Time Frame
2 years post RFA treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric K Hoffer, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
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An Intraoperative Guidance Platform for Radio Frequency Ablation
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