The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose >200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 yr
- •Both sexes eligible for study
- •Patients with primary or secondary liver tumors
- •Liver dominant disease
- •At least one lesion greater than 5.0 cm in maximum diameter
- •Life-expectancy > 3 months
- •FLR >40% or greater than 500mls
- •Must be able to tolerate pre-treatment CT scan , DSA and 99mTc-MAA infusion and imaging with SPECT/CT scan
- •Able to schedule and tolerate post-treatment Y90 PET/CT imaging
- •Able to tolerate follow-up imaging with dynamic contrast CT liver phase or MRI with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.
排除标准
- •Child Pugh > B
- •Bilirubin >2 mg/dl
- •Albumin<3.0
- •Central portal invasion
- •Multi-focal bilobar disease
- •Disseminated extrahepatic disease
- •Lung shunt >20% or a estimated Lung dose > 20 Gy
- •Focuses of extra-hepatic liver uptake.
- •Patients that cannot tolerate addition follow-up imaging.
结局指标
主要结局
Tumor Response
时间窗: 2 years
Complete Response will be measured with the LI-RADS criteria for treatment response (LR-TR). In addition, RECIST v1.1, mRECIST, and PET-RECIST criteria will be further evaluated.
Complications
时间窗: 6 months
Adverse Events related with the procedure
LPFS
时间窗: 2 years
Liver Progression Free Survival after the procedure
次要结局
- Post-treatment dosimetry analysis(2 years)
研究者
Dr. Konstantinos Katsanos
Associate Professor of Interventional Radiology
University Hospital of Patras