Computer Guided Microwave Liver Ablation
NE Scientific INC
84 participants
May 1, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if the intraoperative use of a computer guidance software can improve the success of liver tumor ablation in adults. The employed software calculates and displays a simulation of the ablation such that the physician can visualize what portion of the target tumor has, and has not been treated at any point during the procedure. The main questions it aims to answer are: 1) Does the use of the computer guidance software reduce the number of times a tumor is incompletely treated. 2) Does the use of the computer guidance software reduce the rate of local tumor recurrence at 2 year follow-up? 3) Was there an increase or a decrease in medical problems for participants after a procedure where the guidance software was used? Researchers will compare liver tumor treatment using the computer guidance software with an historic control to see if the addition of the guidance software improved the outcomes after an ablation. Participants will: Undergo CT-guided microwave ablation treatment of a liver tumor using computer-assisted simulation. Visit the clinic at one month and then every 3 months for blood tests and a contrast-enhanced CT or MRI imaging study (as per standard of care)
Eligibility
Inclusion Criteria14
- Age ≥ 18 years, with life expectancy of at least 1 year
- Diagnosis of hepatocellular carcinoma (HCC) confirmed by:
- LI-RADS 5 imaging features or
- Histopathology
- Cirrhosis with AFP > 400
- Localized disease without macrovascular invasion or extrahepatic metastasis, eligible for curative-intent percutaneous thermal ablation, defined as:
- o Up to 5 lesions with at least one lesion, 2 -5 cm, and no lesion >5 cm diameter
- Tumor location deemed technically feasible for percutaneous ablation by the treating interventional radiologist
- ECOG Performance Status 0-2
- Adequate coagulation status, defined as:
- Platelets ≥ 50,000/μL
- INR ≤ 1.8 (or correctable)
- Ability to undergo contrast-enhanced CT or MRI
- Willingness and ability to provide informed consent
Exclusion Criteria9
- Prior local therapy to the target lesion (ablation, TACE, SBRT, or resection) or to a lesion within 1 cm of the target lesion
- More than 5 hepatic lesions, or any lesion ineligible for technically complete ablation
- uncontrolled hepatic decompensation, including:
- o Persistent encephalopathy
- Uncorrectable coagulopathy or contraindication to percutaneous liver intervention
- Contraindication to contrast-enhanced imaging (e.g., severe CKD without dialysis, contrast allergy not correctable with premedication)
- Active systemic infection
- Pregnancy
- Inability to comply with follow-up imaging schedule
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Interventions
Computer-assisted image-processing software used intraoperatively to assist in percutaneous thermal ablation. The software performs segmentation and registration of pre-procedural and intraprocedural imaging, and simulates the expected ablation zone based on probe position, applied energy, and adjacent vascular structures. The output is displayed in 3D multiplanar images to be used by the treating physician to assist in planning, targeting, and intraprocedural decision-making regarding adequacy of ablation coverage. After each ablation activation, the treating physician determines registration accuracy and decides whether any additional ablation is required, based on images of the software estimation of what tissues have and have not been treated.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07226869