PD-L1 Specific 68Ga-THP-PD-L1-3 Probe for PET Imaging in Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Standardized uptake value（SUV）
研究概览
简要总结
The objective of the study is to constrcut a noninvasive approach 68Ga-THP-PD-L1-3 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment.
详细描述
Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years old; ECOG 0 or 1;
- •Patients with solid tumorsin or suspected tumor lesions;
- •life expectancy >=12 weeks.
排除标准
- •Significant hepatic or renal dysfunction;
- •Is pregnant or ready to pregnant;
- •Cannot keep their states for half an hour;
- •Refusal to join the clinical study;
- •Suffering from claustrophobia or other mental diseases;
- •Any other situation that researchers think it is not suitable to participate in the experiment
研究组 & 干预措施
68Ga-THP-PD-L1-3
All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-THP-PD-L1-3 PET/CT scans (At the investigator's discretion, a total of no more than 0.5 mg of non-radiolabeled precursor may be considered for injection. To reduce liver and bone marrow uptake). After resting for 40 minutes or 1 hour, participants underwent United Imaging Healthcare total-body PET/CT for whole body scans or a Siemens Biograph m-CT flow PET/CT from the top of the head to the upper third of the thighs.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Standardized uptake value（SUV）
时间窗: 2 years
The uptake of the tracer （68Ga-THP-PD-L1-3) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.
次要结局
未报告次要终点
研究者
Hua Zhu
Principal Investigator
Peking University Cancer Hospital & Institute