68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects with Solid Tumor or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Biodistribution of 68Ga-grazytracer
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.
详细描述
The investigators recently developed a granzyme B-specific radiotracer named 68Ga-grazytracer. This clinical trial aims to investigate whether granzyme B PET imaging using 68Ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or CAR-T therapy in subjects with solid tumor and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who were diagnosed with malignant tumors;
- •Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
- •participants who had no prior immunotherapy;
- •participants who had no regional therapy within 3 months;
- •Participants aged ≥18 years.
排除标准
- •participants with a concurrent disease that would impede the treatment regimen;
- •Participants who were unable or unwilling to provide written informed consent.
研究组 & 干预措施
Feasibility and safety of 68Ga-grazytracer
The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy.
干预措施: 68Ga-grazytracer (Drug)
结局指标
主要结局
Biodistribution of 68Ga-grazytracer
时间窗: 3 year
The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.
Incidence of 68Ga-grazytracer-emergent Adverse Events
时间窗: 3 year
Any adverse events following the administration of the radiotracer will be monitored.
Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response
时间窗: 3 year
Participants will be categorized into groups with high or low 68Ga-grazytracer uptake in tumor lesions. The progression-free survival and treatment response, as assessed by RECIST 1.1 criteria, will be compared across these groups.
Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer
时间窗: 3 year
The specificity of 68Ga-grazytracer will be validated by correlating the immunohistochemistry results of granzyme B in either surgical or biopsy tissue samples with the standardized uptake values (SUV) of 68Ga-grazytracer in the tumors.
次要结局
- Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype(3 year)