Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Evaluation of the short-term repeatability of ADC maps in both primary and nodal lesions in patients with squamous cell carcinomas (SCC) of the head and neck
研究概览
简要总结
Evaluation of the repeatability and reproducibility of ADC maps in both primary and non-primary lesions lymph nodes in patients with head and neck cancer, using an acquisition protocol Standardized DWI
详细描述
DWI imaging consists of a spin-echo echo-planar sequence (SE-EPI) that will be acquired with 1.5 T or 3 T tomographs according to the equipment of the individual centers involved, setting the acquisition parameters after the administration of any contrast medium.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years;
- •primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology;
- •a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm;
- •specific written informed consent;
排除标准
- •incomplete acquisition of DWI images;
- •presence of artifacts that do not allow quantitative analysis of DWI images;
- •performance status 2 or more according to Zubrod.
研究组 & 干预措施
Patients with primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity c
Patients over 18 years of age with primary squamous cell carcinoma of the head and neck (hypopharynx, oropharynx or oral cavity, confirmed by histology) will be prospectively enrolled and, according to standard procedures, will have to undergo an MRI examination for diagnostic purposes.
结局指标
主要结局
Evaluation of the short-term repeatability of ADC maps in both primary and nodal lesions in patients with squamous cell carcinomas (SCC) of the head and neck
时间窗: 18 months
A standardized and shared DWI acquisition protocol will be used at a multicenter level. DWI imaging consists of a spin-echo echo-planar (SE-EPI) sequence that will be acquired with 1.5 T or 3 T tomographs, setting the acquisition parameters, after the administration of the contrast medium (if any) (in order to ensure that the second DWI acquisition is performed under the same conditions as the first). The MRI study must include at least one T2-weighted axial sequence, whose images will be used to support the delineation of the lesions.
次要结局
未报告次要终点