A Study of PET Imaging of T-cell Activation With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-directed Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
研究概览
简要总结
This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
详细描述
The purpose of this study is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. [18F]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.
A baseline [18F]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older and willing and able to provide informed consent.
- •Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
- •For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.
排除标准
- •Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.
- •Pregnant female patients; breastfeeding female patients.
- •Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
- •Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
- •Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
研究组 & 干预措施
[18F]F-AraG
A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point.
干预措施: [18F]F-AraG Injection (Drug)
结局指标
主要结局
Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
时间窗: Baseline and 10-14 days after first dose of neoadjuvant therapy
Percent Change in standard uptake value (SUV) of \[18F\]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.
Percent pathologic response at the time of surgery
时间窗: At the time of surgery
100% minus the percentage of viable tumor remaining in the tumor bed.
Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient
时间窗: 5 years
Spearman correlation coefficient will be calculated in assessing the correlation between \[18F\]F-AraG uptake and pathologic response.
次要结局
未报告次要终点