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
- 尚未招募
- 入组人数
- 120
- 主要终点
- Number of participants with 18F-G1-related adverse events (AEs).
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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •ECOG performance status≤
- •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
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.
the granzyme B specificity of 18F-G1
时间窗: 3 years
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)