The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tumor uptake of 18F-G1
研究概览
简要总结
The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy
详细描述
It is urgent to select patients who will benefit from immunotherapy, so as to help the clinicians adjust the regimens and avoid unnecessary side effect. 18F-G1 is a new radioactive tracer targeting granzyme B, holding great promise in assessing early response to immunotherapy. This study will explore the safety of 18F-G1 PET/CT in patients with solid tumors and hematological tumors receiving immunotherapy, analyze its imaging features, and assess its efficacy in predicting early immunotherapy response and prognosis, so as to aid the clinicians in precise patient stratification and regimen adjustment.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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
- 是
入选标准
- Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team.
- Subjects didn't receive previous immunotherapy.
- There exists at least one measurable target lesion according to the RECIST 1.1.
- ECOG performance status≤2.
- The expected survival time is ≥6 months.
- Effective contraceptive measures will be adopted during the study period and within 6 months after the study.
- Willing and able to fully understand and sign the informed consent form.
排除标准
- Women in the preconception period, pregnancy, or lactation period.
- Combined with other malignant tumor.
- Diagnosed with autoimmune disease, or have long history of systemic steroid hormone therapy or immunosuppressive therapy.
- Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency.
- Receiving radiotherapy or interventional therapy during the immunotherapy.
- 18F-G1 PET/CT or 18F-FDG PET/CT is not performed in our department, or the interval between baseline imaging and immunotherapy is more than 30 days.
结局指标
主要结局
Tumor uptake of 18F-G1
时间窗: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.
Liver uptake of 18F-G1
时间窗: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.
Lung uptake of 18F-G1
时间窗: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in lung will be quantitatively assessed by SUVmax.
Kidney uptake of 18F-G1
时间窗: 40-60 minutes after the injection of 18F-G1
The uptake of 18F-G1 in kidney will be quantitatively assessed by SUVmax.
the granzyme B specificity of 18F-G1
时间窗: 3 years
Number of participants with 18F-G1-related adverse events (AEs).
时间窗: 3 days after the injection of 18F-G1
The absolute number of participants with AEs after the injection of 18F-G1 according to CTCAE 5.0.
The vivo accumulation and distribution of 18F-G1 in tumors and major healthy organs.
时间窗: 40-60 minutes after the injection of 18F-G1
The accumulation and distribution of 18F-G1 in tumors and major healthy organs, such as liver, lung, kidney, will be quantitatively and qualitatively examined.
Assessing the early predictive value of 18F-G1 PET/CT for immunotherapy response.
时间窗: 6 months
Participants' overall response will be assessed by RECIST 1.1 criteria or Lugano criteria at the time point of 6 months after immunotherapy. The tumor uptake of 18F-G1 will be compared between the responders and non-responders.
次要结局
- Evaluate the correlation of 18F-G1 accumulation in tumors to long term survival after immunotherapy.(3 years)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07039474
- 其他研究编号
- 2025R0069
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否