NCT07370805尚未招募不适用
Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Lung Cancers
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
This study aims to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT in lung cancer.
详细描述
- Patients clinically suspected or confirmed with lung cancer are required to complete conventional imaging examinations (CT/MR or FDG PET) and undergo ¹⁸F-FAPI PET/CT.
- Conduct a detailed inquiry into the patient's medical history to clarify symptoms, signs, and prior medical history (e.g., tumor history, surgical history, biopsy history, radiotherapy history, chemotherapy history, family history, allergy history, etc.), as well as relevant laboratory tests and previous imaging findings (including plain radiography, ultrasound, CT, MRI, 18F-FDG PET/CT, PET/MR, etc.).
- For follow-up coordination, you are required to regularly provide your clinical data (e.g., treatment plans, disease progression, etc.) as per the study requirements. This collaboration is essential for completing long-term follow-up, including monitoring the subject's condition, imaging findings, pathological results (such as tumor grading and Ki-67 index), and patient treatment outcomes, to collect prognostic information.
- ¹⁸F-FAPI PET/CT and conventional imaging examinations (e.g., CT/MR) were completed prior to enrollment. After enrollment in this study, subjects were not required to undergo additional imaging or laboratory tests, only requiring follow-up without intervention to the clinical treatment plan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Lung Cancer
- •With 18F FAPI PET scan
排除标准
- •Concurrent presence of other active malignant tumors or a history of other
- •malignant tumors within the past 5 years;
- •Severe uncontrollable diseases or active infections;
- •Ineligible participants for project informed consent；
- •Pregnant and lactating women.
研究组 & 干预措施
FAPI-Lung-ca
18F FAPI PET scans
干预措施: 18F-FAPI PET (Diagnostic Test)
结局指标
主要结局
Diagnostic efficacy
时间窗: through study completion, an average of 1.5 year
Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET Imaging in lung cancer.
次要结局
- Standard uptake value （SUV）of tumor(through study completion, 3-4 years)
- Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor(through study completion, 3-4 years)
- Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients(through study completion, 3-4 years)
研究者
研究点 (1)
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