NCT04269499已完成不适用
Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary or Secondary Liver Cancer; a Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Feasibility of MR imaged administration of holmium microspheres
研究概览
简要总结
This is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging.
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
- •Patients must have given written informed consent.
- •Female or male aged 18 years and over.
- •Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver (primary tumours: colorectal cancer, melanoma, breast cancer or neuro-endocrine tumour) 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.
- •Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
- •Life expectancy of 12 weeks or longer.
- •World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
- •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.
- •Negative pregnancy test for women of childbearing potential.
排除标准
- •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
- •Radiation therapy within the last 4 weeks before the start of study therapy.
- •The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
- •Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- •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.
- •Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- •Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- •Leukocytes < 4.0 109/l and/or platelet count < 60 109/l.
- •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.
- •Pregnancy or breast feeding (women of child-bearing potential).
- •Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
- •Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- •Patients ineligible to undergo MR imaging.
- •Patients who are claustrophobic.
- •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.
- •Patients who are declared incompetent.
- •Previous enrolment in the present study or previous treatment with radioembolisation.
- •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.
- •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.
- •Untreated active hepatitis.
- •Transjugular intrahepatic portosystemic shunt (TIPS).
- •Body weight over 150 kg (because of maximum table load).
- •Severe allergy for intravenous contrast agents used
- •Iomeron®, because of CT evaluation, pre-treatment angiography and treatment angiography.
- •Dotarem or Primovist, depending on the agent used at the time of treatment
- •Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
- •Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.
结局指标
主要结局
Feasibility of MR imaged administration of holmium microspheres
时间窗: 1 month after inclusion
Feasibility is defined as successful treatment under MRI in at least 4 of 6 patients. Unsuccessful treatment is defined as having to abort the procedure for safety reasons, judged by the interventional radiologist, and having to complete the administration of microspheres under X-ray guidance as in normal practice. Possible reasons for this are uncertainty about the location of the catheter, or luxation of the catheter as a result of transport to the MRI scanner.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 3 months after treatment)
- Tumor/non-tumor ratio on MR based dosimetry(1 month after inclusion)
- Comparison of dosimetry in Gray between MR based and SPECT based dose maps(1 month after inclusion)
- Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria)(3 months after treatment)
研究者
研究点 (2)
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