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临床试验/NL-OMON45911
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

Radboud Universitair Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新:

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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