NCT05183776已完成不适用
Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Validation of a fractional administration device for holmium radioembolization
研究概览
简要总结
To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.
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 or liver metastases originating from colorectal cancer.
- •At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT
- •Patient is eligible for SIRT 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
- •Significant extrahepatic disease (2x sum of diameters of lesions outside the liver > sum of lesions inside the liver)
- •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
- •Glomerular filtration rate (GFR-MDRD) <35 ml/min
- •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)
- •Evidence of clinically relevant, untreated grade 3 portal hypertension
- •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 holmium-166 SPECT/CT
- •Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
结局指标
主要结局
Validation of a fractional administration device for holmium radioembolization
时间窗: 3 months after treatment
The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%.
Safety of a fractional administration device for holmium radioembolization
时间窗: 6 months after treatment
The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's
次要结局
- Accurate dosimetry based on MRI and SPECT imaging of holmium-166.(6 months after treatment)
研究者
研究点 (1)
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