N/A
N=57
An Intraoperative Guidance Platform for Radio Frequency Ablation
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04152343 ↗Enrolled (actual)
57
Serious AEs
3.5%
Results posted
May 2024
Primary outcome: Primary: Rate of Technical Success of Tumor Ablation — 68; 0 tumors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RFA Physics Library -- a Planning and Guidance Platform (PGP) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Technical Success of Tumor Ablation |
68; 0 | — |
| PRIMARY Rate of Local Tumor Recurrence |
9; 59 | — |
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.
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
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.