NL-OMON45911已完成不适用
SPIO- enhanced High Field MRI for restaging lymph node status in rectal cancer: an explorative study - USPIO- enhanced High Field MRI for restaging rectal cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64(—)
入选标准
- •General criteria:
- •- Age > 18 years;Specific ;- Patients with recently histologically proven rectal cancer, who are:;o Planned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² .;and;o Planned to undergo a total mesorectal excision.
排除标准
- •General exclusion criteria:;- Abdominal circumference > 120cm
- •- Pregnancy;- Karnofsky score <= 70;- Contraindications for 3T MRI:
- •o Inability to provide informed consent
- •o Metal implants that are not compatible with 3 Tesla MRI;- Contraindications to USPIO based contrast agents:
- •o prior allergic reaction to ferumoxtran-10 or any other iron preparation
- •o prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
- •o prior allergic reaction to contrast media of any type
- •o hereditary hemochromatosis, thalassemia, sickle cell anemia;;- Contraindications to bisacodyl or butylscopolamine:
- •o cardiac arrhythmia,
- •o myasthenia gravis,
- •o urinary retention,
- •o gastrointestinal stenoses,
- •o kidney failure
- •o glaucoma, ;- Inflammatory diseases of the abdomen (such as Crohn*s disease);- Previous oncological related abdominal and/or pelvic surgery or radiotherapy
研究者
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