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临床试验/NCT01717807
NCT01717807Unknown不适用

C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 30 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
入组人数
30
试验地点
1
主要终点
Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment

研究概览

简要总结

The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.

New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)

Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.

Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.

The purposes of the study are:

  1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
  2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
  • patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.

排除标准

  • lack of histological diagnosis;
  • not a candidate for erlotinib;
  • pregnancy.

结局指标

主要结局

Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment

次要结局

  • size of tumor and metastasis (mm)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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