A clinical imaging Study of the changes in [18F]F-AraG uptake following Radiotherapy in Non-small cell lung cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To assess the relative change in uptake of [18F]F-AraG in tumor lesions on anti-PD-1 treatment. i. To define tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) per [ 18F]F-AraG PET scan using the optimized simplified uptake parameter (SUV, TBR, TPR). ii. To assess the changes in uptake between baseline and after 1 and 3 weeks post-RT, respectively.
研究概览
简要总结
To assess the relative change in uptake of [18F]F-AraG in tumor lesions upon radiotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed NSCLC, melanoma, esophageal, or breast cancer • Ongoing immunotherapy using an anti-PD-(L)1 agent • Planned to be treated with high dose (24Gy) radiotherapy per clinical indication • Be willing and able to provide written informed consent for the trial. • Have a performance status of 0-2 on the ECOG Performance Scale • Be above 18 years of age on day of signing informed consent.
排除标准
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day
- •Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. • Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. • Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of [ 18F]F-AraG.
结局指标
主要结局
To assess the relative change in uptake of [18F]F-AraG in tumor lesions on anti-PD-1 treatment. i. To define tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) per [ 18F]F-AraG PET scan using the optimized simplified uptake parameter (SUV, TBR, TPR). ii. To assess the changes in uptake between baseline and after 1 and 3 weeks post-RT, respectively.
To assess the relative change in uptake of [18F]F-AraG in tumor lesions on anti-PD-1 treatment. i. To define tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) per [ 18F]F-AraG PET scan using the optimized simplified uptake parameter (SUV, TBR, TPR). ii. To assess the changes in uptake between baseline and after 1 and 3 weeks post-RT, respectively.
次要结局
未报告次要终点
研究者
Idris Bahce
Scientific
Amsterdam UMC Stichting