Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of MRI-guided radioembolization procedure
研究概览
简要总结
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
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
- •Diagnosis of hepatocellular carcinoma BCLC stage B or C
- •At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT
- •Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO)
- •Patient has a life expectancy of 12 weeks or longer
- •Patient has a WHO performance score of 0-2
排除标准
- •Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed)
- •Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment
- •Serum bilirubin > 2.0 x the upper limit of normal
- •ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
- •Leukocytes <4.0 * 109/L or platelet count <60 * 109/L
- •Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.
- •Pregnancy or breast feeding
- •Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum
- •Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)
- •Portal vein thrombosis of the main branch (more distal branches are allowed)
- •Untreated, active hepatitis
- •Body weight > 150 kg (because of maximum table load)
- •Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
- •Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT.
- •Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
- •Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.
结局指标
主要结局
Safety of MRI-guided radioembolization procedure
时间窗: 12 months after treatment
Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.
Time constraints of performing intraprocedural MRI-based dosimetry
时间窗: during treatment procedure
Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.
Toxicity profile of dose administration cohorts
时间窗: 12 months after treatment
Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.
Feasibility of performing intraprocedural treatment planning
时间窗: during treatment procedure
The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study.
次要结局
- Dosimetry optimization(12 months after treatment)