IFN-y PET Imaging: Bench to Bedside
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- peak Standard Uptake Value (SUVpeak)
研究概览
简要总结
The goal of this clinical trial is to investigate the use of [89Zr]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.
详细描述
Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.
-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.
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
- •Prior histologic or cytologic diagnosis of non-small cell lung cancer.
- •FDG PET done within 2 months of the baseline imaging, as part of standard-of-care.
- •measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver)
- •must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph.
- •must be >18 years old.
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center.
- •Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging
- •No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator.
- •Pregnant or breast feeding individuals.
排除标准
- 未提供
研究组 & 干预措施
[89Zr]Zr-DFO-emapalumab
Radiotracer [89Zr]Zr-DFO-emapalumab injection
干预措施: [89Zr]Zr-DFO-emapalumab (Drug)
结局指标
主要结局
peak Standard Uptake Value (SUVpeak)
时间窗: Up to Day 45
Descriptively summarize at baseline and post-immunotherapy treatments.
mean Standard Uptake Value (SUVmean)
时间窗: Up to Day 45
Descriptively summarize at baseline and post-immunotherapy treatments.
maximum Standard Uptake Value (SUVmax)
时间窗: Up to Day 45
Descriptively summarize at baseline and post-immunotherapy treatments.
次要结局
- change of SUVpeak(Up to Day 45)
- change of SUVmean(Up to Day 45)
- change of SUVmax(Up to Day 45)
研究者
Nerissa T. Viola
Principle Investigator
Barbara Ann Karmanos Cancer Institute