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Completed

NCT Number: NCT04152343

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RFA Physics Library -- a Planning and Guidance Platform (PGP)

Device

Research software used to support liver RFA of HCC lesions >2cm

Primary outcomes

  1. 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)

    Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.

  2. Rate of Local Tumor Recurrence

    Time frame: 2 years after RFA treatment

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 5, 2019
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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