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临床试验/NCT01812031
NCT01812031已完成不适用

Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Lesion SUVmax

研究概览

简要总结

Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs.

To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.

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
Single (Investigator)

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 has one or more lung lesion(s) less than 35 mm visible on a CT image
  • age : over 18 years
  • patients gave their written informed consent

排除标准

  • pregnancy
  • patient has at least one lesion more than 35 mm in its great axis

结局指标

主要结局

Lesion SUVmax

时间窗: Day 1

For each CT nodule, observer has to report the corresponding (maximum Standardized Uptake Value)SUVmax on ungated and CT-based images (even if there is no obvious uptake)

次要结局

  • Lung function test(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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