Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 8
- 主要终点
- effective tumor dose and safe healthy liver dose
研究概览
简要总结
Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.
Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •over 18 years old
- •histopathologically proven colorectal cancer diagnosis
- •treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion
- •have follow-up data at least 6 months after radioembolization
排除标准
- •no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.
- •No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver
结局指标
主要结局
effective tumor dose and safe healthy liver dose
时间窗: 3th month after treatment
Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.
次要结局
- dose (in Gy) -response and dose (in Gy)-toxicity relationships(6th month after treatment)
研究者
Cigdem Soydal
Asc. Prof. of Nuclear Medicine, MD, FEBNM
Ankara University