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临床试验/NCT04031534
NCT04031534已完成2 期

Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry

Centre Henri Becquerel1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx

研究概览

简要总结

Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Patient with squamous cells carcinoma of oropharynx
  • Age Superior to 10 years old
  • Male or Female
  • measurable target according RECIST criteria

排除标准

  • -Other histologic cancer than squamous cells carcinoma of oropharynx
  • No measurable target
  • Presence of metastasis

研究组 & 干预措施

Measure of hypoxia by F-Miso PET scan and RMI

Experimental

Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy

干预措施: F-Miso PET scan coupled with MRI (Drug)

结局指标

主要结局

Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx

时间窗: 1 year

次要结局

  • Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC)(1 year)
  • Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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