Pilot Study of Real Time MR Temperature Monitoring of Multipolar Radiofrequency Ablation of Large Hepatocellular Carcinomas (≥ 5 CM)-ARMTICH STUDY
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Rate of complete ablation one month after one RFA procedure
研究概览
简要总结
Object of the study:
To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of reduction of the number of procedure required to obtain complete ablation of the tumors.
Experimental plan :
This pilot study consist to perform in a single center a single procedure of the multipolar RF ablation under MR temperature monitoring for the treatment of up to three HCC with diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion of the study will be the rate of complete ablation one month after one RFA procedure performed under MR temperature monitoring. The secondary criteria are, the 2-years local recurrence rate (after the first initial RF ablation procedure performed under MR temperature imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant viable foci of tumor), the potential reduction of the number of RF procedures required to achieve complete necrosis and the complication rate of RF ablation procedure performed under MR temperature monitoring.
In exploratory attempt, the study will include comparative assessment of these criteria with a historic leg of patients previously treated by the same operator in the same center for similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.
详细描述
The RF procedure and results assessment:
- In preparing MR room, the patient will be positioned on MR bed put on dedicated MR compatible trolley. The abdominal antenna will be installed.
- General anesthesia with tracheal intubation will be performed.
- Up to six RF electrodes (up to 6 depending on the size and the location of the tumor) will be inserted under ultrasound guidance.
- The patient will be translated without any direct manipulation in the magnet.
- With usual T1 and T2 weighted MR morphologic sequences the poisoning of electrode will be checked and if necessary adjusted
- Adjustment or MR temperature imaging (before RF energy deposition)
- Starting of RF procedure under MR temperature monitoring
- According to thermal dose maps data repositioning of electrodes and complementary energy deposition if necessary
- Hot withdrawal of electrodes
- Immediate (T0) post procedure MR assessment of the limits of ablation zone (T2 SPIRCHOL, Diffusion B600, In out phase, THRIVE dynamic after intravenous gadolinium injection).
After the procedure patients will be monitored at least 48 h.
MR assessment of treatment response will be performed one month after the procedure (same MR protocol performed at T0).
If the ablation is complete follow up will be ensured by MR every three months. If the ablation appeared incomplete or in case of recurrence additional RF ablation will be performed if the patient stills met the criteria of the treatment. The eventual additional RF ablation will be performed under ultrasound monitoring (the response to each additional RF ablation procedure will be assessed by MR one month after).
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
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
- •Patient of 18 year old.
- •Up to 3 tumors unresectable suspected to be HCC according the criteria as previously defined by EASL and recently revised by AASLD among them at least one having a maximal diameter equal or larger than 5 cm.
- •Proof of underlying cirrhosis.
- •Multidisciplinary decision of RF ablation treatment
- •Informed consent of patient
- •Available healthcare insurance
排除标准
- •Patient with short term life training uncontrollable disease
- •Pregnancy
- •Follow up Impossible
- •Contra indication for general anesthesia
- •Contra indication for MR examination with gadolinium injection
- •Tumor located at less than 10 mm from colonic wall or main biliary tract
- •Tumor invisible on MR examination
- •Absence of safe percutaneous course to puncture the tumor
- •Child - Pugh B or C cirrhosis
- •Abundant ascites
- •PROTHROMBIN activity < 50 %
- •Platelet count < 40 .10 3/ml
- •Antecedent of ascitis decompensation
- •Severe portal hypertension defined by the presence of large oesophageal variceal (grade 2) , of radiological ascitis or umbilical vein repermeabilisation
- •Elevation of transaminases (>3 upper limit normal range)
- •Antecedent of biliodigestive anastomosis
- •Antecedent of endoscopic sphincterotomy
结局指标
主要结局
Rate of complete ablation one month after one RFA procedure
时间窗: One month after one RFA procedure
次要结局
- Number of procedure required to achieve complete ablation(One month after completion of treatment course)
- Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 RFA procedures performed monthly)(1 month after completion of treatment)
- 2-years local recurrence rate(2 years)
- Complication rate per RF procedure under MR temperature monitoring(2 years)
- Agreement of 2D and 3D measurements of ablations zones on IRMT° images and those measured on conventional magnitude MR images.(during and after the procedure (one month after))