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临床试验/NCT01549730
NCT01549730进行中(未招募)不适用

A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Number of patients treated with the PET tracer FAZA to image primary tumor hypoxia in patients with cervix cancer prior to treatment with radiotherapy and concurrent cisplatin chemotherapy

研究概览

简要总结

The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300 patients. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.

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

入选标准

  • Age ≥18 years
  • Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
  • TNM (7th edition) cT1-4, N0-1, M0-1
  • Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
  • No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
  • A negative urine or serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age
  • Ability to provide written informed consent to participate in the study

排除标准

  • Prior complete or partial hysterectomy
  • Carcinoma of the cervical stump
  • Inability to lie supine for more than 30 minutes
  • Patients taking the drug disulfuram (Antabuse)

结局指标

主要结局

Number of patients treated with the PET tracer FAZA to image primary tumor hypoxia in patients with cervix cancer prior to treatment with radiotherapy and concurrent cisplatin chemotherapy

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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