SPIO- enhanced High Field MRI for restaging lymph node status in rectal cancer: an explorative study - Nano-MRI in locally advanced rectal cancer

Radboudumc0 个研究点开始时间: 2016年8月8日最近更新: 2016年10月3日

试验速览

暂无简介。

•General criteria:
•-Age > 18 years
•Inclusion criteria rectal cancer patients:
•-Patients with recently histologically proven rectal cancer, who are:
•oPlanned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² .
•oPlanned to undergo a total mesorectal excision.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•General exclusion criteria:
•-Abdominal circumference > 120cm
•-Pregnancy
•-Karnofsky score <= 70
•-Contraindications for 3T MRI:
•oInability to provide informed consent
•oMetal implants that are not compatible with 3 Tesla MRI
•-Contraindications to USPIO based contrast agents:
•oprior allergic reaction to ferumoxtran-10 or any other iron preparation
•oprior allergic reaction contributed to dextran or other polysaccharide, in any preparation
•oprior allergic reaction to contrast media of any type
•ohereditary hemochromatosis, thalassemia, sickle cell anemia;
•-Contraindications to bisacodyl or butylscopolamine:
•ocardiac arrhythmia,
•omyasthenia gravis,
•ourinary retention,
•ogastrointestinal stenoses,
•okidney failure
•-Inflammatory diseases of the abdomen (such as Crohn’s disease)
•-Previous abdominal surgery or radiotherapy

发起方