Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
研究概览
简要总结
The SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90 radioembolization of liver cancer.
详细描述
Short-acting gelatin sponge particles will be used during radioembolization to protect normal liver tissue in patients with liver cancer whose treatment field encompasses a substantial portion of non-tumorous liver tissue. Recanalization of the embolized hepatic artery will be assessed by angiography within 30 minutes following the procedure. Suppression of Y90 microsphere delivery to the protected, non-tumorous liver tissue will be evaluated using Y90 PET-CT imaging, by comparing the protected regions to non-protected, non-tumorous regions within the perfused area. Enhanced tumor uptake of Y90 microspheres will be quantified using the tumor-to-normal liver ratio (TNR), calculated by comparing pre-procedure SPECT-CT with post-procedure PET-CT data. Finally, preservation of liver function in protected tissue relative to unprotected tissue will be assessed six months post-procedure using signal intensity ratios on hepatobiliary phase images obtained from gadoxetic acid-enhanced MRI.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients diagnosed with primary or metastatic liver cancer based on histological and/or radiological findings
- •Patients determined, following medical, surgical, or multidisciplinary evaluation, to be best treated by radioembolization
- •Patients with no history of local treatments (e.g., ablation, chemoembolization) to the same hepatic lobe within the past year
- •Child-Pugh class A
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- •Patients whose treatment area, as determined by planning angiography, includes at least two liver segments
- •Patients for whom normal liver tissue constitutes 50% or more of the treatment volume
排除标准
- •Liver cancer with vascular invasion
- •For primary liver cancer, patients who have been diagnosed with a malignancy other than the primary liver cancer within 2 years prior to study enrollment
- •Patients who have undergone biliary-enteric anastomosis
- •Patients with an estimated lung dose of 30 Gy or higher on pre-procedure 99mTc-MAA imaging
- •Patients with a known contraindication to gelatin use
研究组 & 干预措施
Test group
short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver.
干预措施: NexGel (Device)
结局指标
主要结局
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
时间窗: Day 1, The day after radioembolization
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
次要结局
- Angiographic recanalization of the transiently embolized hepatic arteries(After Y-90 microsphere infusion, 30 minutes after embolization)
- Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)(Day 1, The day after radioembolization)
- Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver(6 months after radioembolization)
- Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI(6 months after radioembolization)
- Response to the treatment, as assessed by mRECIST(6 months after radioembolization)
- Serious adverse event(For 6 months from radioembolization)