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临床试验/NCT02862678
NCT02862678已完成不适用

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

CHU de Reims1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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