Evaluation of the Value of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of [18F]AlF-NOTA-PCP2 PET/CT imaging for PD-L1 expression in malignant tumors
研究概览
简要总结
This phase I/II clinical trial evaluates the safety, efficacy, and prognostic potential of [18F]AlF-NOTA-PCP2 PET/CT imaging in assessing PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer. The primary aim is to establish the correlation between [18F]AlF-NOTA-PCP2 uptake and PD-L1 expression in tumor tissues, while secondary objectives include evaluating its role in predicting clinical outcomes such as progression-free survival (PFS) and overall survival (OS). By providing a non-invasive, quantitative, and reproducible method for assessing PD-L1, this study aims to refine patient stratification and improve the precision of immunotherapy decision-making.
详细描述
This phase I/II clinical trial is designed to explore the utility of [18F]AlF-NOTA-PCP2 PET/CT in evaluating PD-L1 expression and its prognostic implications in patients with malignant tumors (glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer). The study involves at least 20 patients (5 per tumor type) who will undergo a pre-treatment PET/CT scan following an intravenous injection of [18F]AlF-NOTA-PCP2. The primary endpoints include the safety of the imaging protocol and the correlation between [18F]AlF-NOTA-PCP2 uptake (SUV values) and PD-L1 expression determined through immunohistochemistry (IHC). Secondary endpoints explore the dynamic changes in SUV values in patients undergoing multiple scans and their relationship with clinical outcomes.
Scientific and Technical Rationale:
[18F]AlF-NOTA-PCP2 is a novel radiotracer with high specificity for PD-L1, enabling non-invasive imaging of its expression in vivo. This imaging approach complements traditional immunohistochemical methods by offering whole-body assessment, eliminating the need for repeated biopsies, and providing insights into the tumor microenvironment. This study seeks to validate its application in clinical oncology, bridging molecular imaging with biomarker-guided therapeutic strategies.
Study Methods:
Patients will receive a single intravenous dose of [18F]AlF-NOTA-PCP2 (adjusted for body weight), followed by a whole-body PET/CT scan after one hour. Images will be analyzed independently by two experienced nuclear medicine specialists. Tumor biopsies will be collected to measure PD-L1 expression via IHC, and blood samples will be assessed for circulating and exosomal PD-L1 biomarkers. For patients undergoing multiple scans, changes in radiotracer uptake will be tracked to monitor treatment response.
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
盲法说明
This study is open-label, with no masking of any parties involved in the clinical trial. All participants, care providers, investigators, and outcomes assessors are aware of the interventions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained.
- •Age ≥ 18 years, any gender.
- •Pathologically confirmed malignant tumors, including:
- •Glioblastoma
- •Head and neck squamous cell carcinoma
- •Non-small cell lung cancer
- •Esophageal cancer
- •Detectable PD-L1 expression in tumor tissue (based on immunohistochemistry or biopsy).
- •Measurable disease with at least one residual tumor lesion.
- •ECOG performance status of 0-
- •No contraindications to [18F]AlF-NOTA-PCP2 PET/CT imaging.
- •Willing and able to comply with study procedures and follow-up visits.
排除标准
- •Participation in another interventional clinical trial.
- •Failure to recover from toxic effects or complications of prior interventions (≤ grade 1 or baseline levels, excluding fatigue or hair loss).
- •Pregnant or breastfeeding women.
- •Severe or uncontrolled systemic diseases, including:
- •Major, symptomatic arrhythmias or significant ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher heart block, or ventricular arrhythmias).
- •Unstable angina or congestive heart failure (NYHA class ≥ 2).
- •Any arterial thrombotic or embolic events within 6 months before enrollment (e.g., myocardial infarction, cerebrovascular accident, transient ischemic attack).
- •Active or uncontrolled infections requiring systemic treatment.
- •Severe psychiatric disorders affecting study participation.
- •Any medical history, laboratory abnormality, or condition that may:
- •Interfere with study results.
- •Affect patient participation.
- •Pose an unacceptable risk as determined by the investigator.
- •Women of childbearing potential without a negative pregnancy test prior to study entry.
- •Known allergy or hypersensitivity to [18F]AlF-NOTA-PCP2 or any component of the radiopharmaceutical.
结局指标
主要结局
Assessment of [18F]AlF-NOTA-PCP2 PET/CT imaging for PD-L1 expression in malignant tumors
时间窗: Pre-treatment imaging, within 1-7 days before treatment initiation.
This outcome measure will assess the safety and efficacy of \[18F\]AlF-NOTA-PCP2 PET/CT in detecting PD-L1 expression in malignant tumors (glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer). This will include evaluating the correlation between \[18F\]AlF-NOTA-PCP2 uptake and PD-L1 expression as determined by immunohistochemistry (IHC).
次要结局
- [18F]AlF-NOTA-PCP2 PET/CT imaging as a prognostic biomarker in malignant tumors(Up to 1 year of follow-up for clinical outcomes (PFS, OS).)
研究者
Man Hu
Chief physician
Shandong Cancer Hospital and Institute