Computer Guided Microwave Liver Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Local Tumor Progression
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Imaging outcomes will be assessed by independent radiologists blinded to intervention status
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Inability to comply with follow-up imaging schedule
研究组 & 干预措施
Computerized Guidance
Patients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance.
干预措施: Computer-Assisted Microwave Liver Ablation (Device)
结局指标
主要结局
Local Tumor Progression
时间窗: Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months).
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.
Technical Effectiveness
时间窗: 1 month post-procedure
Technical Effectiveness is defined as complete ablation of all target tumor tissue, demonstrated by the absence of any nodular or irregular arterial phase enhancement within or along the margin of the ablation zone on the first post-ablation contrast-enhanced imaging study (CT or MRI). This assessment is performed approximately one month after the procedure. Imaging is interpreted according to LI-RADS treatment response criteria (LR-TR) or equivalent institutional criteria.
次要结局
未报告次要终点