Clinical trial · Interventional
Computer Guided Microwave Liver Ablation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer-Assisted Microwave Liver Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Computerized Guidance
- description
- Patients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance.
- interventionNames
- Device: Computer-Assisted Microwave Liver Ablation
Primary outcomes (2)
- measure
- Local Tumor Progression
- timeFrame
- Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months).
- description
- Local Tumor Progression (LTP) is defined as the appearance of new or enlarging nodular or irregular arterial phase enhancement with washout at or within the edge of a previously ablated lesion after an earlier imaging study has demonstrated complete ablation (technical effectiveness). LTP is determined on serial contrast-enhanced CT or MRI according to LI-RADS treatment response criteria or equivalent institutional standards.
- measure
- Technical Effectiveness
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years, with life expectancy of at least 1 year 2. Diagnosis of hepatocellular carcinoma (HCC) confirmed by: * LI-RADS 5 imaging features or * Histopathology * Cirrhosis with AFP \> 400 3. 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 4. Tumor location deemed technically feasible for percutaneous ablation by the treating interventional radiologist 5. ECOG Performance Status 0-2 6. Adequate coagulation status, defined as: * Platelets ≥ 50,000/μL * INR ≤ 1.8 (or correctable) 7. Ability to undergo contrast-enhanced CT or MRI 8. Willingness and ability to provide informed consent Exclusion Criteria: 1. Prior local therapy to the target lesion (ablation, TACE, SBRT, or resection) or to a lesion within 1 cm of the target lesion 2. More than 5 hepatic lesions, or any lesion ineligible for technically complete ablation 3. uncontrolled hepatic decompensation, including: o Persistent encephalopathy 4. Uncorrectable coagulopathy or contraindication to percutaneous liver intervention 5. Contraindication to contrast-enhanced imaging (e.g., severe CKD without dialysis, contrast allergy not correctable with premedication) 6. Active systemic infection 7. Pregnancy 8. Inability to comply with follow-up imaging schedule
References
Publications (2)
- BACKGROUNDHoffer 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. Epub 2022 Jan 14. PMID 35039220
- BACKGROUNDHoffer EK, Drinane MC, Bhatnagar V, Mehta R, Munger DP, Borsic A. Radiofrequency ablation of hepatocellular carcinoma guided by real-time physics-based ablation simulation: a prospective study. Int J Hyperthermia. 2024;41(1):2331704. doi: 10.1080/02656736.2024.2331704. Epub 2024 Mar 19. PMID 38503326