Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
研究概览
简要总结
Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.
This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult (>18)
- •Informed consent
- •CHC Child-Pugh stage A or B, BCLC stage B
- •Referred for chemoembolization of a non-surgery-candidate CHC
- •Blood test results compatible with cTACE (INR ≤ 1,5, ASAT/ALAT<5N, albumine>2,5g/dl)
排除标准
- •Contraindication to cTACE, angiography, confocal laser endomicroscopy or liver biopsy Hyperthyroidism
- •Contraindication to the use of fluorescein, Ariblastine,Lipiodol, Visipaque, Gelita spon, Avitene
- •extra hepatic metastasis
- •Subcapsular or exophytic tumor impeding direct percutaneous access through healthy liver tissue
- •Waiting list for liver transplant
- •Complete portal venous thrombosis or flow inversion
- •Pregnancy or breast feeding
- •Protected major (Guardianship)
- •Patient in situation of exclusion (determined by a previous or ongoing study)
- •Subject incapacity to understand informed consent
研究组 & 干预措施
Normal saline
Doxorubicin solution reconstituted in 5 mL normal saline
干预措施: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline (Drug)
Iodinate contrast
Doxorubicin solution reconstituted in 5 mL iso-osmolar ionic iodinated contrast media
干预措施: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media (Drug)
结局指标
主要结局
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
时间窗: T3: 1 min after cTACE drug injection is completed
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
次要结局
- In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution(1 min after cTACE drug injection is completed,)