Validation of USPIO-enhanced MRI for detection of lymph node metastases in head and neck carcinoma: a pilot study. - Validation of nano-MRI in head and neck carcinoma.

Radboudumc0 个研究点目标入组 25 人开始时间: 2018年12月11日最近更新: 2019年2月28日

适应症

试验速览

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•- Males and females aged >18 years.
•- Patients with histopathologically proven cT0-4N0-2M0 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or unknown primary.
•- Patients planned for a neck dissection.
•- Patients providing informed consent
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•- Patients who underwent radio- and/or chemotherapy to the neck before surgery.
•- Patients who had a previous lymphadenectomy in the head and neck region.
•- Patients who are pregnant and/or breast-feeding.
•Patients with contraindications to MRI:
•- Epilepsy
•- Metallic implants
•Patients with contraindications to ferumoxtran-10:
•- prior allergic reaction to ferumoxtran-10 or any other iron preparation
•- prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
•- prior allergic reaction to contrast media of any type
•- hereditary hemochromatosis, thalassemia, sickle cell anemia

发起方