Correlation of Necrosis With DC Bead LUMI (TM) Distribution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS
研究概览
简要总结
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled.
详细描述
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Primary endpoint : Local response (evaluated with CT and MRI at 4 to 6 weeks post each procedure and at 6 months according to mRECIST) in patients with intermediate-stage HCC following chemoembolisation with radiopaque bead. Secondary endpoints include: 1) Better definition of end point of embolization for drug eluting beads : Ability to achieve near-stasis during chemoembolisation procedure in the tumour feeding vessels using intra-procedural imaging feedback from the radiopaque bead (early visualization of non target embolization 2) Total dose needed for tumor devascularization 3)Distribution of radiopaque beads and correlation with necrosis and adverse events
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years old.
- •HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
- •Barcelona Criteria Liver Cancer (BCLC) stage B patients or BCLC stage A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation).
- •Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
- •Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/
- •Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A score and Child/Pugh B≤ 7 points ) without ascites.
- •Total bilirubin ≤2.0 mg/dl.
- •Adequate renal function (serum creatinine < 1.5 X ULN).
- •Patient has provided written informed consent.
排除标准
- •Patient previously treated with any intra-arterial therapy for HCC.
- •Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
- •Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl.
- •Advanced tumoural disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=ECOG of 1-2) or D class (WHO performance status 3 or 4, Okuda III stage).
- •Patient with another primary tumour.
- •Patient with refractory ascites or on diuretic treatment; minor ascites retention detected at imaging and not requiring diuretics to be solved is not a contraindication.
- •Patient with history of biliary tree disease or biliary dilatation.
- •Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
- •Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
- •Any other contraindication for embolisation or local doxorubicin treatment.
- •Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before study treatment.
- •In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- •Pregnant or breast-feeding women.
结局指标
主要结局
CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS
时间窗: 12 months
Local response following chemoembolisation
次要结局
- Distribution of radiopaque beads and correlation with necrosis(12 months)
- Total dose needed for tumor devascularization(12 months)
- Definition of end point of embolization for drug eluting beads(12 months)
研究者
Malagari Katerina
ASSOCIATE PROFESSOR
University of Athens