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临床试验/NCT01610544
NCT01610544撤回2 期

A Pilot Study of 18F FLT PET/CT in Evaluating Early Response to Anti-Proliferative Therapies in Non Small Cell Lung Cancer and Thymic Tumors

National Cancer Institute (NCI)0 个研究点开始时间: 2012年5月10日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
撤回
主要终点
To explore the relationship between change in 18F FLT tumor uptake and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

研究概览

简要总结

Background:

  • Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans are used to detect tumor responses to cancer treatment. However, it may be difficult to detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These scans cannot easily show a difference between remaining cancer cells and inflammation. Researchers want to try a new PET/CT scan tracer that may be able to show the difference between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are still actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are responding to early stages of treatment.

Objectives:

  • To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer response to treatment.

Eligibility:

  • Individuals at least 18 years of age who are being treated for lung cancer or thymoma.

Design:

  • Participants will be screened with a physical exam and medical history. Blood, urine, and tumor tissue samples will be collected.
  • Participants will have two PET/CT scans on separate days before starting chemotherapy. One scan will be with a standard radiotracer. The other will be with the 18F-FLT tracer.
  • About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT scans on separate days. Additional blood samples will be collected at this time.

详细描述

Background:

  • (18)F FLT, a thymidine analog, has uptake in tumors that correlates with proliferative rates and may be an early predictor of tumor response.
  • Due to uptake in inflammatory tissues, routinely used (18)F FDG PET/CT is often unable to distinguish therapeutic response from reactive change early in therapy.
  • Molecularly targeted therapies relating to the MEK kinase pathway in non small cell lung cancer (NSCLC) and the IGF pathway (anti-IGF-1R monoclonal antibodies) in thymoma, affect tumor proliferation.
  • We intend to explore the potential utility of (18)F FLT PET/CT imaging as an early marker of therapeutic response in molecularly targeted therapies relating to the MEK kinase pathway in NSCLC and the IGF pathway in thymic tumors.

Objectives:

-To explore the relationship between change in (18)F FLT tumor uptake (pre-treatment and soon after initiation of treatment (2 weeks)) and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

Eligibility:

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To explore the relationship between change in 18F FLT tumor uptake and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

次要结局

  • To explore the relationship between the absolute pre-treatment 18F FLT uptake and the clinical response to therapy
  • To determine if the change in 18F FLT uptake is different from the change in 18F FDG PET/CT at the same time points

研究者

申办方类型
Nih
责任方
Sponsor

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