非小细胞肺癌患者厄洛替尼治疗期间的治疗诊断工具 (FLT-THERA)
放射性标记 3'-脱氧-3'-(18)F-氟-L-胸苷的正位发射断层扫描能否成为非小细胞肺癌患者厄洛替尼治疗期间的治疗诊断工具?
在法国,肺癌是癌症导致死亡的主要原因。 在使用阻断表皮生长因子受体 (EGFR) 的酪氨酸激酶受体抑制剂(如厄洛替尼)治疗不可切除的非小细胞肺癌 (NSCLC) 方面取得了治疗进展。
这种药物通常不会引起 NSCLC 肿瘤的快速缩小,这解释了为什么在治疗 8 周后厄洛替尼的 RECIST 标准不如细胞毒性药物可靠。
在无法切除的 NSCLC 患者中,3'-脱氧-3'-18F-氟-L-胸苷 (18F-FLT) 和 18F-2-18F-氟-2-脱氧-D-葡萄糖 (18F-FDG) 正电子发射断层扫描(PET) 已经确定了厄洛替尼一线和二线或三线的早期反应患者和更好的无进展生存期。
迄今为止,尚未进行任何医学经济学研究来确定该策略是否具有成本效益。
本研究的目的是通过在厄洛替尼治疗第 14 天(二线或以上)确定对厄洛替尼无反应的受试者,即 6根据新的 RECIST 1.1 进行形态学评估前几周,通常在厄洛替尼治疗的第 8 周进行。
将实现卫生经济学辅助研究。 事实上,最近的治疗改进,特别是非小细胞肺癌的靶向治疗,提高了生活质量和预期寿命,但也导致了健康成本的显着增加。 根据研究,NSCLC 治疗的平均成本在过去 10 年中增加了 3 倍。 更有效的策略允许以客观终点提前停止,昂贵的疗法是胸部肿瘤学的主要成就。
这项工作的潜在临床影响是 1) 在无反应者中早期停止厄洛替尼并在他们的身体状况恶化之前更换另一种治疗,2) 降低副作用的风险和不必要治疗的成本,以及 3) 提出定制方案一线治疗后的治疗。
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Gironde
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Bordeaux、Gironde、法国、33000
- University Hospital, Bordeaux
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Haut de Seine
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Percy、Haut de Seine、法国、92140
- Army Hospital, Percy
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Haute Garonne
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Toulouse、Haute Garonne、法国、31000
- University Hospital, Toulouse
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Indre et Loire
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Tours、Indre et Loire、法国、37000
- University Hospital, Tours
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Maine et Loire
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Angers、Maine et Loire、法国、49933
- University Hospital, Angers
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Meurthe et Moselle
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Nancy、Meurthe et Moselle、法国、54000
- University Hospital, Nancy
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Seine maritime
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Rouen、Seine maritime、法国、76000
- University Hospital, Rouen
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Val de Marne
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Créteil、Val de Marne、法国、94000
- Hospital, Créteil
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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
描述
纳入标准:
- 18岁以上
- 经组织活检证实为非小细胞肺癌
- 已知 EGFR 突变状态,没有激活的 EGFR 突变
- 至少接受过一次既往治疗后厄洛替尼治疗的指征
- 已签署知情同意书参与本研究的患者
- 预期寿命超过 12 周
- WHO 活动得分在 0 到 2 之间。
排除标准:
- 开始使用厄洛替尼的禁忌症
- 拒绝签署同意书
- 进行性炎症性疾病
- 感染艾滋病病毒
- 其他恶性疾病
- 预期寿命少于 12 周
- 受法国法律保护的主要成年人
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:实验臂
所有患者都将在同一只手臂上。
患者将有两个 18F-FLT-TEP 和两个 18F-FDG-TEP:第一个发生在厄洛替尼开始前的两周内,第二个发生在厄洛替尼开始后的第二周内。
TEP 的顺序不明确:18F-FLT-TEP 可以先计划,也可以依次计划。
两个 TEP 必须间隔 48 小时。
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患者将有两次 18F-FLT-TEP:一次发生在厄洛替尼开始前的两周内,第二次发生在厄洛替尼开始后的第二周内。
患者将接受两次 18F-FDG-TEP:一次发生在厄洛替尼开始前的两周内,另一次发生在厄洛替尼开始后的第二周内。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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通过 18F-FLT 和 18F-FDG PET 扫描早期预测对厄洛替尼治疗的反应
大体时间:六个月
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主要终点是第 56 天通过 RECIST 1.1 形态学成像评估的厄洛替尼肿瘤反应(被认为是金标准)与第 7 天之前和之后通过 PET 评估的 18F-FLT 和 18F-FDG 摄取变化之间的相关性根据标准 PERCIST 开始使用厄洛替尼。将使用 Kappa 测试。
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六个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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通过 18F-FLT 和 18F-FDG PET 扫描早期预测厄洛替尼治疗反应的经济学研究
大体时间:六个月
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本研究的目的是确定是否可以通过早期预测对厄尔替尼治疗的反应来最大限度地减少健康成本。
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六个月
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合作者和调查者
合作者
调查人员
- 首席研究员:José HUREAUX, MD, PhD、University Hospital, Angers
- 学习椅:Olivier COUTURIER, MD, PhD、University Hospital, Angers
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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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
18F-FLT-TEP的临床试验
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University of IowaNational Cancer Institute (NCI); National Institutes of Health (NIH)完全的
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Hamad Medical Corporation终止
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Hamad Medical Corporation未知原发性血小板增多症 | 原发性骨髓纤维化,纤维化前期 | 原发性骨髓纤维化,纤维化阶段卡塔尔