ano MRI on 7 Tesla: A technical validation study in rectal and breast cancer

Radboudumc0 个研究点开始时间: 2015年1月7日最近更新: 2015年3月9日

适应症

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 planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.
•Inclusion criteria breast cancer patients:
•-Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•General exclusion criteria:
•-BMI > 30 kg/m2
•-Pregnancy
•-Karnofsky score <= 70
•-Contraindications for 7T MRI:
•oInability to provide informed consent
•oMetal implants that are not compatible with 7 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;
•Exclusion criteria for rectal cancer:
•-Inflammatory diseases of the abdomen (such as Crohn’s disease)
•-Previous abdominal surgery or radiotherapy
•Exclusion criteria for breast cancer:
•-Prior radiotherapy or surgery to axillae

发起方