NL-OMON45742已完成不适用
Real-time MR imaged treatment with holmium microspheres of patients with primary or secondary liver cancer; a single center, interventional, non-randomized, feasibility study. - Real Time MR imaged holmium radioembolisation.
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. Patients must have given written informed consent.
- •2. Female or male aged 18 years and over.
- •3. Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
- •4. Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
- •5. Life expectancy of 12 weeks or longer.
- •6. World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
- •7. One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- •8. Negative pregnancy test for women of childbearing potential.
排除标准
- •1. Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week
- •2. Radiation therapy within the last 4 weeks before the start of study therapy.
- •3. The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
- •4. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- •5. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
- •6. Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- •7. Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- •8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- •9. Leukocytes < 4.0 10^9/l and/or platelet count < 150 10^9/l.
- •10. Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease >=2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •11. Pregnancy or breast feeding (women of child-bearing potential).
- •12. Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
- •13. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- •14. Patients ineligible to undergo MR imaging.
- •15. Patients who are claustrophobic.
- •16. Patient who had prior liver resection and/or coil placement inside the liver, expected to cause imaging artefacts on MRI that will limit MR quantification.
- •17. Patients who are declared incompetent.
- •18. Previous enrolment in the present study or previous treatment with radioembolisation.
- •19. Portal vein thrombosis (tumour and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
- •20. Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
- •21. Untreated active hepatitis.
- •22. Transjugular intrahepatic portosystemic shunt (TIPS).
- •23. Body weight over 150 kg (because of maximum table load).
- •24. Severe allergy for intravenous contrast agents used
- •a. Iomeron®, because of CT evaluation, pre-treatment angiography and treatment angiography.
- •b. Dotarem or Primovist, depending on the agent used at the time of treatment
- •25. Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
- •26. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.
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