An Intraoperative Guidance Platform for Radio Frequency Ablation

Not Applicable

Completed

Conditions: Hepatocellular Carcinoma

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

Registration Number: NCT04152343

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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:
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
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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA Physics Library- PGP	RFA Physics Library -- a Planning and Guidance Platform (PGP)	The RFA Physics Library will be used during during percutaneous liver RFA procedures.

Primary Outcome Measures

Name	Time	Method
Rate of Local Tumor Recurrence	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.
Rate of Technical Success of Tumor Ablation	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.

Secondary Outcome Measures