Clinical Application of PD-L1 Targeted Imaging Agent ⁶⁸Ga-DPA in the Diagnosis of Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SUV
研究概览
简要总结
In previous studies, we synthesized a PD-L1-targeted molecular probe, ⁶⁸Ga-DPA, and developed a ⁶⁸Ga-DPA injection for clinical research. Preliminary studies demonstrated its favorable safety profile and excellent imaging performance. Leveraging the established strengths of the Department of Nuclear Medicine at Peking Union Medical College Hospital, we now plan to conduct an exploratory PET/CT imaging study in lung cancer patients. This study aims to provide an in vivo, non-invasive, and visualizable technique for detecting PD-L1 expression levels and spatial distribution in tumors. It will further validate the clinical utility of this technology, offering critical diagnostic insights for initial assessment and treatment efficacy evaluation in PD-L1-positive tumor patients undergoing PD-L1-targeted therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, regardless of gender.
- •Patients clinically confirmed or suspected of lung cancer, with pathological specimens obtainable via biopsy or surgery within the recent 2 months.
- •At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Expected survival >3 months.
排除标准
- •Severe hepatic or renal dysfunction (serum creatinine >3.0 mg/dL or any liver enzyme level ≥5× upper limit of normal).
- •Women who are planning pregnancy, pregnant, or breastfeeding.
- •Inability to lie supine for 30 minutes.
- •Claustrophobia or other psychiatric disorders.
- •Intolerance to any clinical procedures in the study.
- •Other conditions deemed ineligible by the investigator.
研究组 & 干预措施
68Ga-DPA PEWT/CT
干预措施: 68Ga-DPA PET/CT (Diagnostic Test)
结局指标
主要结局
SUV
时间窗: 0-180 minutes post-injection
measured by PET/CT
次要结局
未报告次要终点