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2018年12月11日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: ymph node metastases in patients with squamous cell head and neck carcinoma.
发起方: Radboudumc
入组人数: 25
状态: 进行中（未招募）
最后更新: 7年前

暂无简介。

注册库

who.int

开始日期

2018年12月11日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

•\- 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