68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- To define the diagnostic performance 68Ga-FAPI PET
研究概览
简要总结
This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.
详细描述
FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years
- •Informed consent obtained from patients and families
- •Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
- •Patients scheduled to undergo FDG-PET examination
- •Performance status: 0, 1, 2, 3
排除标准
- •Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
- •Patients with mainly malignant pleural effusion without other measurable lesions
- •Undergoing irradiation at accrual
- •Active infection or other serious underlying medical conditions not compatible with study entry
- •History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent
研究组 & 干预措施
68Ga-FAPI-46 PET Scan
A single-center prospective interventional single-arm clinical trial. All patients will undergo whole-body 68Ga-FAPI-46 PET scan within two weeks before or after 18F-FDG-PET. Injected activity of 68Ga-FAPI-46 is limited to 100-250 MBq per examination.
干预措施: 68Ga-FAPI-46 (Diagnostic Test)
结局指标
主要结局
To define the diagnostic performance 68Ga-FAPI PET
时间窗: Through study completion, 2 years
To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.
次要结局
- To determine the safety profile of 68Ga-FAPI PET(Up to 7 days post injection with 68Ga-FAPI-46)
研究者
HO, KUNG-CHU
Principal Investigator
Chang Gung Memorial Hospital