Evaluating T Cell Changes and Activation in Cancer Patient Using Two PET Tracers (iRelate)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Main trial endpoints and their analysis: The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method. The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.
研究概览
简要总结
Primary objectives: To measure the spatial correlation of PET uptake of [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab in tumors and T-cell rich organs such as lymph nodes prior to resection. To measure the strength of correlation between the presence of CD8+ cells and T cell activation features in the resected tumor and lymph nodes with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG, respectively.
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
- •To be eligible to participate in this study, a patient must meet all of the following criteria:
- •Histologically confirmed NSCLC, melanoma, esophageal or triple negative breast cancer
- •Lesion size of ≥2cm, at time of the (re)staging FDG PET/CT
- •Planned to undergo resection according to routine treatment guidelines
- •Neoadjuvant chemotherapy + IO is allowed
- •Willing and able to provide written informed consent for the trial
- •Above 18 years of age on day of signing informed consent
- •Have measurable disease based on RECIST 1.15
- •Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in this study:
- •Patients deemed inoperable
- •Patients 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.
结局指标
主要结局
Main trial endpoints and their analysis: The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method. The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.
Main trial endpoints and their analysis: The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method. The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.
次要结局
- Secondary trial endpoints and their analysis: The Pearson correlation coefficient between each tracer tumor uptake and percentage of residual viable tumor cells (VTC) in regions of concordance and discordance and the maximal VTC of the whole of the tumor. The Pearson correlation coefficient between each tracer uptake and the T cell features in resected lymph nodes (if present).
研究者
Idris Bahce
Scientific
Amsterdam UMC