Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- tumor recurrence
研究概览
简要总结
Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.
详细描述
study the diagnostic performance of diffusion MRI performed in early post treatment, notably changes in the ADC factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat.
compare the characteristics of diffusion MRI, such as ADC coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients with head and neck squamous cell carcinoma
- •patients with indication of a treatment by chemoradiotherapy (without surgical indication)
- •patient consenting to participate to the study
- •patient enrolled in the national healthcare insurance program
- •patient older than 18 years
排除标准
- •patients with contraindications for MRI
研究组 & 干预措施
Patients with head and neck squamous cell carcinoma
干预措施: diffusion-weighted MRI (Other)
结局指标
主要结局
tumor recurrence
时间窗: 12 months
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
次要结局
- residual tumors(6 months)