Clinical trial NCT04152343: An Intraoperative Guidance Platform for Radio Frequency Ablation
Official title: An Intraoperative Guidance Platform for Radio Frequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Radiofrequency Ablation
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Technical Success of Tumor Ablation
timeFrame: Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
measure: Rate of Local Tumor Recurrence
timeFrame: 2 years after RFA treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Eric K Hoffer, MD
role: PRINCIPAL_INVESTIGATOR
References: