Clinical Impact of a Volumetric Image Method for Confirming Tumor Coverage With Ablation on Patients With Malignant Liver Lesions (COVER-ALL)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.
研究概览
简要总结
This phase II trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. The current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (CT) scans. Software-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate if the intra-procedure feedback of a biomechanical deformable registration volumetric image method during percutaneous ablation will increase the minimal ablation margins on a three-dimensional computed tomography-generated analysis.
SECONDARY OBJECTIVES:
I. To assess whether applying the proposed method during percutaneous ablation improves local tumor progression-free survival (LTPFS) rates.
II. Evaluate impact of software use on procedure workflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with ≤ 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 5 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation. Patients with more than 3 tumors might also be eligible in case other tumors can be treated with another curative-intended loco-regional therapy (i.e. surgical resection, radiation therapy).
- •Ability to completely cover the target tumor with at least a 5 mm ablation margin.
- •Written informed consent to voluntarily participate in the study and follow-up CT scan schedule
- •Age > 18 years-old
- •Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG])
- •Target tumor should be visualized on contrast-enhanced CT
- •Adequate glomerular filtration rate
排除标准
- •Active bacterial infection or fungal infection on the day of the ablation that, in the opinion of the investigator, would interfere with safe delivery of the study procedure or with the interpretation of study results.
- •Platelet < 50,000/mm
- •Patients with uncorrectable coagulopathy.
- •Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
- •Physical or psychological condition which would impair study participation.
- •ASA (American Society of Anesthesiologists) score of >
- •Any other loco-regional therapies at the target lesion(s) within 30 days of the ablation procedure.
结局指标
主要结局
Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.
时间窗: Visit 2 (baseline/ablation day)
For control group, MAM was assessed by rigid co-registration with side-by-side juxtaposition to verify applicator placement and by visual landmark-based CT measurements on CT workstation (Siemens Healthineers; Forchheim, Germany). For experimental group, CT images were processed with a software-based method on a radiation treatment planning system (Raystation, RaySearch Laboratories; Stockholm, Sweden) with biomechanical deformable imaging registration coupled with AI-based autosegmentation. For experimental group, interventional radiologist (IR) was informed of ablation applicator position relative to tumor on non-contrast CT before thermal ablation energy delivery and of MAM results (including spatial location of suboptimal margins) generated by software-based assessment, with this information not disclosed to IR in control group. Software-based assessment was used to compare MAMs results between both study groups with a two-sample t-test.
次要结局
- Cumulative Incidence of 2-year Local Tumor Progression(Time to local tumor progression (LTP) was measured from ablation to earliest LTP or death (competing event). Follow-up imaging continued up to 24 months.)
- Overall Survival(Overall survival was measured from the date of ablation to the date of death from any cause. Patients still alive were censored at the date of last clinic visit, with follow-up up to 24 months after ablation.)
- Intrahepatic Progression-free Survival (for the Randomized Group)(Up to 2 years)
- Extrahepatic Progression-free Survival(Up to 2 years)