跳至主要内容
临床试验/NCT07343271
NCT07343271招募中不适用

Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Overall agreement established by interclass correlation on the T stage of TNM

研究概览

简要总结

The diagnostic and pre-therapeutic assessment of squamous cell carcinomas requires a neck and chest CT scan and a neck and facial MRI, which is the most effective examination, to establish the TNM stage of the tumor. However, obtaining this complete assessment can delay treatment. Confirmation of the non-inferiority of 40keV dual-energy CT in BOLT compared to MRI would spare the patient an additional MRI examination, speed up the pre-treatment assessment, reduce the loss of opportunity due to delayed treatment, and free up MRI imaging slots, which are still insufficient in the region.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient (≥18 years)
  • presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy
  • having undergone a clinical examination with nasofibroscopy by an ENT surgeon specializing in cancer surgery
  • a contrast-enhanced cervicofacial MRI
  • and a contrast-enhanced cervicofacial DECT with BOLT maneuver.

排除标准

  • A lesion other than oral or oropharyngeal squamous cell carcinoma
  • A labial location
  • A contraindication to performing one or both of the imaging examinations.

结局指标

主要结局

Overall agreement established by interclass correlation on the T stage of TNM

时间窗: Up to 12 months

Overall agreement established by interclass correlation on the T stage of TNM between the radiological analysis of the DECT 40 kev BOLT, and of the MRI, compared to the reference T stage of TNM from the RCP: Overall agreement: This means: do the methods give the same results? We want to know if DECT and MRI reach the same T stage for the same patient. Example: DECT: T3 MRI: T3 Result: Good agreement DECT: T2 MRI: T3 Result: Disagreement

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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