DRKS00014139进行中（未招募）4 期
Safety and Efficacy of Ho-166-Radioembolisation by SPECT- and MR-Image guidance optimized substrate application - a comparative Study to Y-90-Radioembolisation - HOLOGRAMM I
niversitätsklinikum Magdeburg0 个研究点目标入组 11 人开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Patients with histopathological and cytological validated non-resectable and/or non-ablative intrahepatic mCRC od Mamma-CA with a liver-only or liver-predominant intra-hepatic spread after exhausted treatment compliant with standards,
- •- ECOG performance status of 0 - 1,
- •- Estimated life expectancy of at least 3 months without any active intervention/treatment, ?
- •- Patients have to be eligible for both treatment options (arm A: SIR-Spheres or arm B: QuiremSpheres) according to the clinical assessment of the treating observer/physician (considering labor-chemical evaluation, results from Tc-99m-MAA evaluation plus further results from clinically available imaging e.g. whole-body F-18-FDG PET/CT)
排除标准
- •- Liver-lung-shunt > 20 % or lung exposure >= 25 Gy from application of the radioembolisate,
- •- Preceding external radio therapy of the liver,
- •- Presence of a clinically liver insufficiency,
- •- Anormal vessel anatomy from pre-therapeutic angiogram, with possibility of a significant back flow of hepatic arterial blood into stomach, pancreas or bowel (extra-hepatic-abdominal accumulation from Tc-99m-MAA liver perfusion scintigraphy) which was unremedied by a re-evaluation (Dudeck et al 2012 CVIR),
- •- Treatment with Capecitabin during the last two months before therapy or a planned treatment with Capecitabin early after therapy with QuiremSpheres® or SIR-Spheres®,
- •- Conventional chemotherapy within the last two weeks. (CTx associated hepatotoxicity has to be decreased to < CTCAE grad 2),
- •- Kidney insufficiency restricting contrast-media enhanced imaging (e.g. angiography),
- •- Existence of a contraindication for contrast-media enhanced MRI (e.g. incompatible cardiac pacemaker, limiting kidney insufficiency),
- •- Intra-hepatic lesion immeasurable by RECIST criteria,
- •- Non-liver predominant tumor disease,
- •- Suspicion of untreated metastasis/metastases of the CNS from clinically or imaging examinations,
- •- Pregnancy or nursing,
- •- Within 28 days before randomization participation in an active part of another clinical study, potentially affecting any endpoint of the current study,
- •- Verification of a persisting active infection, affecting execution of treatment or outcome.
研究者
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