Dynamic PET CT as a Tool for Treatment Efficacy Monitoring in Lung Cancer
研究概览
地位
条件
详细说明
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:
- To assess the feasibility of baseline Dynamic PET-CT as a tool for assessing response for anti-cancer therapy in Lung Cancer patients.
- To predict early response to treatment as soon as after 1 cycle of therapy by dynamic and static PET-CT.
- To correlate Dynamic PET-CT with survival/disease free survival
Method:
200 advanced lung cancer patients will be enrolled over 3 years in a single institute, single arm study at Rabin Medical Center, Beilinson Hospital.
Patients will be evaluated by a Dynamic PET-CT protocol: before initiation of therapy, 7-14 days after the first therapy cycle, 3 months after initiation of therapy and 6 months after the first therapy cycle. In addition, non-invasive biomarkers that are routinely measured including protein markers (CEA- Carcinoembryonic Antigen, CYFRA21- Cytokeratin 19 Fragment, NSE- Neuron Specific Enolase) will be assessed in this trial.
Disease response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST criteria).
Additional PET-CT will not increase radiation dose significantly. The mean estimated radiation dose for a limited CT of the chest is about 14 mSv (i.e., 7mSv for limited diagnostic CT and FDG ([18F]-fluorodeoxyglucose), each). The dynamic stage will add radiation dose of about 0.3mSv. Of note, the significance of adding radiation dose is less of importance with regard to treatment of patients with aggressive cancer.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Petach Tikva、以色列、49100
- Rabin Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant or lactating women.
- Anti cancer therapy within the last 6 weeks before enrollment.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Lung cancer
People that were diagnosed with advanced lung cancer.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Compare baseline PET-CT with PET-CT after 7-14 days.
大体时间:12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
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Evaluate disease-free survival (DFS) in lung cancer by using dynamic PET-CT.
大体时间:12 months
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12 months
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Evaluate overall survival rate (OS) in lung cancer by using dynamic PET-CT.
大体时间:12 months
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12 months
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Measuring response to treatment by PET-CT.
大体时间:12 months
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12 months
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合作者和调查者
调查人员
- 首席研究员:Nir Peled, MD PhD FCCP、Rabin Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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