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Computer Guided Microwave Liver Ablation

RecruitingNAAges 18 Years - 90 YearsAllNE Scientific INC
NCT07226869 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 additio

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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 โ‰ฅ 50,000/ฮผL * INR โ‰ค 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
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What it tests

  • Computer-Assisted Microwave Liver Ablation
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Where

2 sites
Massachusetts General Hospital
Boston, United States
Dartmouth HItchcock Medical Center
Lebanon, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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