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临床试验/NCT02505685
NCT02505685Unknown不适用

Dynamic PET CT as a Tool for Treatment Efficacy Monitoring in Lung Cancer

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Compare baseline PET-CT with PET-CT after 7-14 days.

研究概览

简要总结

The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.

详细描述

Background:

Lung cancer is a devastating disease in which the response for first line therapy is only 30%. Evaluating response is performed normally by a CT or PET-CT scans after 2-3 cycles of therapy, thus, lack of response is been evaluated only after the patient has been treated following significant amount of therapy, which is inefficient in 70% of cases.

Therefore, there is an urgent need to develop tools that might predict response to therapy during the early course of therapy; Most valuable will be before or after the first cycle of therapy. For that reason, the investigators aim in this study to evaluate the use of Dynamic PET-CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.

Objectives:

  1. To assess the feasibility of baseline Dynamic PET-CT as a tool for assessing response for anti-cancer therapy in Lung Cancer patients.
  2. To predict early response to treatment as soon as after 1 cycle of therapy by dynamic and static PET-CT.
  3. To correlate Dynamic PET-CT with survival/disease free survival

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years.
  • Lung cancer, stage 4
  • Patients are planned to be treated by a systemic anti-cancer therapy.
  • A define lesion for imaging.
  • Able and willing to sign an informed consent form.
  • First line therapy or at least 6 weeks after previous line of therapy

排除标准

  • Pregnant or lactating women.
  • Anti cancer therapy within the last 6 weeks before enrollment.

结局指标

主要结局

Compare baseline PET-CT with PET-CT after 7-14 days.

时间窗: 12 months

次要结局

  • Measuring response to treatment by PET-CT.(12 months)
  • Evaluate overall survival rate (OS) in lung cancer by using dynamic PET-CT.(12 months)
  • Evaluate disease-free survival (DFS) in lung cancer by using dynamic PET-CT.(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nir Peled

Professor

Rabin Medical Center

研究点 (1)

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