Computer Guided Microwave Liver Ablation

Обзор

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)

Подробное описание

Accublate (NE Scientific, Inc) is a computer-based tumor ablation guidance software that uniquely provides real-time simulation of expected ablation volumes. In a previously reported study of Radiofrequency Ablation, the improved visualization of treated versus untreated target tumor was associated with improved outcomes. This study examines clinical application of the simulation software for microwave ablation (MWA), which will be evaluated in a 24 month two-center clinical trial.

At Dartmouth Hitchcock Medical Center (DHMC), and at one other hospital, under IRB approval, adults referred from local Liver Tumor Boards for curative local treatment of up to four Hepatocellular Carcinoma (HCC) tumors of 2-5 cm diameter will be offered participation.

After providing informed consent, and meeting inclusion and exclusion criteria, the CT-guided MWA ablation will be performed, with the physician having the benefit of the graphical display of the Accublate MWA simulation guidance software. Prior to the ablation, the software provides 3D graphical display for planning, that includes the tumor, desired margin, and interactive model of the ablation probe and superimposed expected ablation volume at particular energy settings. During placement, the software permits registration of updated image of the actual probe position to original image of the segmented tumor, and with the interactive ablation volume settings, allows assessment of adequacy of targeting. After each activation of the ablation, the calculated simulated ablation volume is provided to indicate what tissues have, and have not, been ablated. These 3D views then provide guidance for intraprocedural adjustments to ensure target coverage by overlapping ablations, if indicated.

Patients are routinely admitted for overnight observation and receive IV pain and nausea medication if needed. One month after the ablation, patients will have a follow-up outpatient contrast-enhanced abdominal CT, and from these images, the rate of complete ablation (Technical Efficacy) will be determined. Additionally, patients will be followed at 3 month intervals for 24 months after the ablation to detect any complications, tumor recurrence (Local Tumor Progression), and survival.

Вмешательства

• Устройство Computer-Assisted Microwave Liver Ablation
  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

Первичные конечные точки

• Local Tumor Progression [Срок оценки: Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months).]
• Technical Effectiveness [Срок оценки: 1 month post-procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Massachusetts General Hospital — Boston
• Dartmouth HItchcock Medical Center — Lebanon

Публикации

• Hoffer 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
• Hoffer 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

Идентификаторы

NCT: NCT07226869 · NES_2025_01 · 1R44CA287803-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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