NL-OMON50197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 - CONTRO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diagnosis of hepatocellular carcinoma or liver metastases originating from
- •colorectal cancer
- •2. At least one lesion of 10 mm in the longest diameter on contrast-enhanced
- •MRI or contrast-enhanced CT
- •3. Patient is eligible for SIRT as determined by the tumour board (in Dutch:
- •4. Patient has a life expectancy of 12 weeks or longer
- •5. Patient has a WHO performance score of 0-2
排除标准
- •1. Significant extrahepatic disease (2x sum of diameters of lesions outside the
- •liver > sum of lesions inside the liver)
- •2. Radiation therapy, chemotherapy or major surgery within 4 weeks before
- •3. Serum bilirubin > 2.0 x the upper limit of normal
- •4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
- •5. Glomerular filtration rate (GFR-MDRD) <35 ml/min
- •6. Leukocytes <4.0 * 10^9/L or platelet count <60 * 10^9/L
- •7. Significant heart disease that in the opinion of the physician increases the
- •risk of ventricular arrhythmia.
- •8. Pregnancy or breast feeding
- •9. Disease with increased chance of liver toxicity, such as primary biliary
- •cirrhosis or xeroderma pigmentosum
- •10. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants,
- •11. Portal vein thrombosis of the main branch (more distal branches are allowed)
- •12. Evidence of clinically relevant, untreated grade 3 portal hypertension
- •13. Untreated, active hepatitis
- •14. Body weight > 150 kg (because of maximum table load)
- •15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
- •16. Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT
- •17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in
- •the falciform ligament, portal lymph nodes or gallbladder are accepted.
研究者
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