NL-OMON55061招募中不适用
Individualized dosimetry for holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: iHEPAR - iHEPAR
niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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 HCC established according to the Netherlands HCC guideline
- •criteria (in line with American AASLD criteria): nodule >1 cm in a patient at
- •risk for HCC, with combination of arterial hypervascularity and venous or
- •delayed phase wash-out on multiphase CT-scan or MRI-scan.2, 4 LR-5 and LR- 4
- •based on Liver Imaging Reporting and Data System can be included.
- •4. No curative treatment options (resection, transplant, or in case of solitary
- •tumor <5 cm, RFA).
- •5. Life expectancy of at least 6 months.
- •6. ECOG Performance status 0-1.
- •7. Liver-dominant disease (maximum 5 lung nodules all <=1.0 cm, solitary
- •clinically stable adrenal metastasis, and mesenteric or portal lymph nodes all
- •<=2.0 cm are accepted).
- •8. Child-Pugh class A5-6 or B7 (only for patients with known cirrhosis).
- •9. At least one measurable liver lesion according to the modified RECIST
- •10. Negative pregnancy test for women of childbearing potential. Female
- •patients of childbearing potential should use a highly effective acceptable
- •method of contraception (oral contraceptives, barrier methods, approved
- •contraceptive implant, long-term injectable contraception, intrauterine device
- •or tubal ligation) or should be more than 1 year postmenopausal or surgically
- •sterile during their participation in this study (from the time they sign the
- •consent form), to prevent pregnancy
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Evidence of significant extrahepatic disease (MRI-scan liver and multiphase
- •abdominal CT as well as a thoracic CT are routinely performed at screening).
- •2. Hepatic radiation therapy within the last 4 weeks before the start of study
- •3. Previous or current treatment with RE. Previous treatment with TACE,
- •surgery, RFA, and previous or current treatment with sorafenib are allowed.
- •4. Major surgery within 4 weeks or incompletely healed surgical incision before
- •starting study therapy.
- •5. Serum bilirubin >34.2 micromole/L (2 mg/dL).
- •6. Glomerular filtration rate <35 ml/min.
- •7. Non-correctable INR >1.5 in case of femoral approach (as opposed to radial).
- •8. Leukocytes <2 109/l and/or platelet count <50 109/l.
- •9. 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.
- •10. Pregnancy or breastfeeding.
- •11. Patients suffering from psychic disorders that make a comprehensive
- •judgment impossible, such as psychosis, hallucinations and/or depression.
- •12. Patients who are declared incapacitated.
- •13. Previous enrollment in the present study.
- •14. Male patients who are not surgically sterile or do not use an acceptable
- •method of contraception during their participation in this study (from the time
- •they sign the consent form), to prevent pregnancy in a partner.
- •15. 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.
- •16. Portal vein thrombosis (tumor 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.
- •17. Untreated active hepatitis. In case of detectable viral HBV load,
- •appropriate treatment should be instituted.
- •18. Transjugular intrahepatic portosystemic shunt (TIPS).
- •19. Body weight over 150 kg (because of maximum table load).
- •20. Severe allergy for intravenous contrast used (Visipaque®)(because of CT
- •evaluation, pre-treatment angiography and treatment angiography).
- •21. Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
- •22. Uncorrectable extrahepatic deposition of scout dose activity. Activity in
- •the falciform ligament, portal lymph nodes and gallbladder is accepted.
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