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临床试验/NCT02717221
NCT02717221已完成不适用

An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging

Harbin Medical University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
tumor SUVmax value of 18F-MPG PET/CT Imaging

研究概览

简要总结

The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status. And use 18F-MPG to monitor EGFR-TKIs and chemotherapy treatment efficiency.

详细描述

The goal of investigators were to evaluate the use of 18F-MPG as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-MPG in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers. And the investigators want to evaluated the use of 18F-MPG in adult NSCLC patients with EGFR mutational status received non-treatment, EGFR-TKIs and chemotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Advanced NSCLC
  • 18 years or older
  • A life expectancy of at least 12 weeks
  • Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
  • Written informed consent

排除标准

  • Claustrophobia
  • Pregnancy
  • Metal implants in the thorax

结局指标

主要结局

tumor SUVmax value of 18F-MPG PET/CT Imaging

时间窗: at time of imaging

To quantify the accumulation, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest.

次要结局

未报告次要终点

研究者

发起方
Harbin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xilin Sun

Chief

Harbin Medical University

研究点 (1)

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