Thermal Ablation With a Loosely Wound Helical Coil for Radiofrequency Treatment of Large Renal and Hepatic Tumors in Patients Undergoing Partial or Total Nephrectomy or Heptectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- RF electrodes can be accurately and safely placed in the desired location
研究概览
简要总结
This is a clinical research study designed to determine the safety and efficacy of the application of a unique interstitial radio frequency thermal therapy for the treatment of large tumours in the kidney or liver. The novel device offers patients a more effective therapy than conventional RFA and for patients with large tumours fewer number of treatments and needle insertion sites. The clinical treatment volumes (or sites of focal tumours) will be determined by a combination of biopsy and contrast enhanced CT imaging.
The study will assess if novel device can produce lesions in the liver or kidney in a controlled and predictable manner and with sufficient size to effectively manage disease progression in the organ. The extent of lesion size at a delivered power setting and treatment time will be measured with post-treatment CT or MRI and biopsy as measures of tissue response
详细描述
Our group has developed a novel, interstitial induction coil device that has been designed to coagulate large tumours (≥3cm) through a single needle insertion using heat in the range 55-90 ◦C. [31]Our system consists of a helical coil that is loosely wound inside the tumour tissue or phantom and excited with radiofrequency energy at 27.12 MHz. The coil is constructed from Nitinol, a shape memory alloy, to permit percutaneous deployment of the device from a cannulating delivery needle into the tumor target. This novel monopolar device has the potential to treat larger tumours with larger ablation zones (6cm x 4cm) with shorter treatment time, in both ex vivo and in vivo settings. In our previous pig studies our group has not seen a decrease in ablation volume compared to the ex vivo studies. The intent of this research proposal is to determine the safety and efficacy of the application of a unique interstitial coil electrode RF thermal therapy device for ablating large human renal and hepatic tumors under US or CT guidance.
- Hypothesis
Interstitial thermal therapy in the form of RF energy delivered percutaneously under US or CT guidance with our newly developed novel coil electrode is a safe and effective method to ablate large renal and hepatic tumors. This is an alternative to immediate surgery or to surveillance with possible delayed treatment.
- Objectives
3.1 To use the novel RF device and technique in liver tumor as developed in the porcine model to patients with heptacellular carcinoma by:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •subjects with a solid renal mass who are undergoing partial or radical nephrectomy
- •subjects with a solid hepatic masses of heptacellular carcinoma or metastatic liver tumour booked for partial or radical hepatectomy
排除标准
- •irreversible coagulation defects,
- •hepatic infection,
- •no extra hepatic malignant disease,
- •venous invasion and/or
- •morbid obesity
研究组 & 干预措施
Acute
The RFA Loosely wound thermal coil electrode will be inserted directly or percutaneously into the lesion, depending on the imaging modality (US or CT guidance) and deployed with same method as previously described in the 'delayed group'. Energy will be delivered using the single timed heating cycle. Treatment will be monitored with B mode US. Once the cycle is completed, the probe will be removed and the planned surgery will continue with partial or radical nephrectomy.
干预措施: RFA Loosely wound thermal coil (Device)
Delayed
Using an electrically insulated 12ga introducer with trocar is inserted percutaneously into the renal tumor. The needle tip will be placed 20mm from the center of the target. The trocar is removed and co-axially (i.e. within the introducer), a core biopsy of the lesion is performed with a 14-18 gauge needle. The radiofrequency applicator with a 14ga cannula containing the RFA Loosely wound thermal coil electrode is then optimally positioned and locked into the introducer. On approximately day 6-10, a partial or radical nephrectomy will be performed in the usual way.
干预措施: RFA Loosely wound thermal coil (Device)
结局指标
主要结局
RF electrodes can be accurately and safely placed in the desired location
时间窗: up to 10 days prior to surgery and up to 24 hrs after surgery
this will be assessed during the surgery and once the tumour is removed and examined
次要结局
- The safety of energy application with the RF coil device including assessing effect on surrounding liver tissue(up to 10 days prior to surgery and up to 24 hrs after surgery)
- Verifying that large (>2cm) liver tumors are effectively ablated with RF energy(up to 24hrs after surgery)