A Prospective Study of [18F]AlF-NOTA-QHY-04 PET/CT for Predicting Outcome in Patients With Limited-Stage Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Progression Status at 6 Months After Completion of Concurrent Chemoradiotherapy (CCRT)
研究概览
简要总结
This prospective observational study aims to evaluate the clinical value of CXCR4-targeted PET/CT imaging in patients with limited-stage small cell lung cancer (LS-SCLC).
Patients diagnosed with LS-SCLC at Shandong Cancer Hospital and Institute underwent [18F]AlF-NOTA-QHY-04 PET/CT imaging before receiving standard concurrent chemoradiotherapy. Imaging findings were analyzed and correlated with clinical outcomes, including progression-free survival, to explore the potential role of CXCR4 PET/CT as a prognostic imaging biomarker.
The results of this study may help improve risk stratification and outcome prediction in patients with limited-stage small cell lung cancer.
详细描述
This was a single-center, prospective observational study conducted at Shandong Cancer Hospital and Institute to investigate the prognostic value of CXCR4-targeted PET/CT imaging in patients with limited-stage small cell lung cancer (LS-SCLC).
Eligible patients with histologically confirmed LS-SCLC underwent [18F]AlF-NOTA-QHY-04 PET/CT imaging prior to standard concurrent chemoradiotherapy. PET/CT parameters reflecting CXCR4 expression were measured and analyzed.
Patients were subsequently followed up according to routine clinical practice. Clinical outcomes, including progression-free survival and overall survival, were recorded during follow-up. The association between baseline CXCR4 PET/CT imaging findings and clinical outcomes was evaluated to explore the potential role of CXCR4-targeted PET/CT as a prognostic imaging biomarker in LS-SCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed limited-stage small cell lung cancer (T1-4N0-3M0) according to the AJCC TNM 8th edition.
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Presence of measurable disease according to RECIST version 1.
- •Newly diagnosed patients who had not received any prior anticancer treatment.
- •Underwent baseline [18F]AlF-NOTA-QHY-04 PET/CT imaging prior to treatment.
排除标准
- •Presence of autoimmune diseases or active comorbid infections.
- •Pregnancy or breastfeeding.
- •Unable or unwilling to provide informed consent.
研究组 & 干预措施
Limited-Stage Small Cell Lung Cancer Cohort
Patients with histologically confirmed limited-stage small cell lung cancer who were enrolled prospectively and received standard-of-care treatment according to institutional protocols.
结局指标
主要结局
Progression Status at 6 Months After Completion of Concurrent Chemoradiotherapy (CCRT)
时间窗: 6 months after completion of concurrent chemoradiotherapy (CCRT)
Progression status assessed at 6 months after completion of concurrent chemoradiotherapy (CCRT) using imaging evaluation according to RECIST version 1.1. Participants were classified as having progression (Progressors) or no progression (Non-progressors).
次要结局
- Progression-Free Survival (PFS)(From date of enrollment until the date of first documented progression (per RECIST version 1.1) or date of death from any cause, whichever came first, assessed up to 36 months)
研究者
Jie Liu
Principal Investigator
Shandong Cancer Hospital and Institute