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: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: RFA Physics Library -- a Planning and Guidance Platform (PGP)

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥ 18 years of age
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. Absolute of relative contraindication to MRI:

   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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.	Device: RFA Physics Library -- a Planning and Guidance Platform (PGP); Research software used to support liver RFA of HCC lesions >2cm

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric K Hoffer, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: November 2, 2019
• First Submitted That Met QC Criteria: November 2, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 15, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• 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: No
• Studies a U.S. FDA-regulated device product: No