An Intraoperative Guidance Platform for Radio Frequency Ablation

Hepatocellular Carcinoma Clinical Trial

Official title:

An Intraoperative Guidance Platform for Radio Frequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152343
• Other study ID #: SF19108
• Secondary ID: 2R44CA189515
• Status: Completed
• Phase: N/A
• Start date: December 7, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Technical Success of Tumor Ablation	Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.	Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
Primary	Rate of Local Tumor Recurrence	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.	2 years after RFA treatment