N/A Completed N=57 Treatment

An Intraoperative Guidance Platform for Radio Frequency Ablation

Hepatocellular Carcinoma

Source: ClinicalTrials.gov NCT04152343 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

May 2024

Primary outcomePrimary: Rate of Technical Success of Tumor Ablation — 68; 0 tumors

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Technical Success of Tumor Ablation	68; 0	—
PRIMARY Rate of Local Tumor Recurrence	9; 59	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04152343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.