68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression
研究概览
简要总结
To evaluate the potential usefulness of 68Ga-NK224 positron emission tomography/computed tomography (PET/CT) for the evaluation of PD-L1 expression in primary and/or metastatic tumors, compared with histopathological results.
详细描述
Participants with cancer underwent 68Ga-NK224 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the PD-L1 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-NK224 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) adult patients (aged 18 years or order);
- •(ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
- •(iii) patients who had scheduled 68Ga-NK224 PET/CT scans;
- •(iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
排除标准
- •(i) patients with non-malignant lesions;
- •(ii) patients with pregnancy;
- •(iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
Experimental: 68Ga-NK224 PET/CT
Each participant receives a single intravenous injection of 68Ga-NK224, and undergo PET/CT imaging within the specified time.
结局指标
主要结局
The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression
时间窗: 30 Days
For 68Ga-NK224 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. For histopathological results, the level of PD-L1 expression is quantified as low (\<1%), medium (1-49%), and high (\>49%), respectively. Finally, Kruskal-Wallis test will be used to test the concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression.
次要结局
- Evaluate the intra- and inter- tumor heterogeneity(30 Days)