跳至主要内容
临床试验/NCT05361551
NCT05361551招募中不适用

Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Quality of Life Questionnaire (EQ-5D-3L)

研究概览

简要总结

To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment. Currently, such methods are only utilized in isolation and the benefit of a combined and standardized procedure workflow is unknown. Therefore, our primary goal of this single-arm clinical trial is to investigate the technical efficacy of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins for the treatment of patients referred to ablation for the treatment of primary and secondary liver cancers.

详细描述

Primary Objective:

To evaluate the technical efficacy and Local Tumor Progression-free survival [LTPFS] of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins, for the treatment of patients with colorectal liver metastasis referred to percutaneous liver ablation.

Secondary Objectives:

To evaluate the impact of this high-precision liver ablation technique on:

  1. Impact of minimally ablated margins on LTPFS
  2. 3D Minimal ablation margins;
  3. Adverse events;
  4. Liver function;
  5. Tissue properties from US elastography;
  6. Contrast-media utilization and radiation exposure;
  7. Overall oncological outcomes (disease-free and overall survival, and ability to provide salvage local therapy at the time of recurrence).
  8. Anesthesia/procedural time
  9. Response and Duration of response
  10. Assessing whether ringenhancing hypervascular liver micronodules represent metastasis

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
  • Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
  • Distance to central bile ducts > 1 cm;
  • Adequate glomerular filtration rate (GFR > 40) and no severe allergies to iodine contrast-media;
  • Ability to understand and the willingness to sign written informed consent;
  • Age > 18 years-old;
  • Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG]);
  • Expected survival > 12 months.

排除标准

  • Use of other prior or concomitant local therapy at the target tumor(s).
  • Active bacterial infection or fungal infection on the day of the ablation.
  • 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).
  • Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.

研究组 & 干预措施

Liver ablation

Experimental

The ablation procedure will be performed in 1 day

干预措施: Liver ablation (Procedure)

结局指标

主要结局

Quality of Life Questionnaire (EQ-5D-3L)

时间窗: through study completion, an average of 1 year

The scale is numbered from 0-100 (100 means the best health you can imagine. 0 means the worst health you can imagine)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验