跳至主要内容
临床试验/NCT01889212
NCT01889212终止不适用

Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC

University of Aarhus2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib

研究概览

简要总结

New treatment strategies have been developed in lung cancer targeting the Epidermal Growth Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds rates to the treatment and should be treated with a EGFR inhibitor as first line of treatment. Some wild type patients do as well respond but selection of these patients is more difficult.

Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer (11C-erlotinib) in tumors has showed promising results for selection of responders.

The investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.

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

  • Lung Cancer patients with non-small cell histology and stage IV disease who are candidate for erlotinib treatment as first/ second/ third line of treatment

排除标准

  • pregnancy
  • severe dyspnoea

结局指标

主要结局

Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib

时间窗: From date of inclusion until the date of first documented progression on the erlotinib treatment or date of death, whichever came first, assessed up to 30 months

Accumulation of 11c-erlotinib in tumors will be correlated to PFS on erlotinib treatment.

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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