Liquid Biopsy in Combination With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer
研究概览
简要总结
The purpose of this study is to determine if a liquid biopsy, a method of detecting cancer from a blood draw, combined with a PET/CT scan, a type of radiological scan, is better at determining whether a lung nodule is cancerous when compared to a PET/CT scan alone. A PET/CT scan is already used for diagnosis of lung nodules, but its efficacy is uncertain in nodules 6-20 mm in size. Therefore, the PET/CT will be evaluated for its diagnostic ability in lesions this size alone and in combination with a liquid biopsy. Secondarily, a machine learning model will be created to see if the combination of the PET/CT imaging data and the liquid biopsy data can predict the presence of cancer.
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
- •Over 18 years of age
- •ECOG performance status of 0,1, or 2
- •Newly discovered lung nodule with:
- •At least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening CT
- •No single lesion larger than 20 mm in greatest diameter when multiple nodules present
- •High- or intermediate-risk nodules per American College of Chest Physician (ACCP) guidelines
- •Able to provide informed consent
排除标准
- •Prior cancer of any type for the previous 3 years
- •Prior organ, bone marrow, of hematopoietic stem cell transplant
- •Contraindication to administration of [18F]FDG
- •Inability to undergo a PET/CT scan
- •Ongoing infection, either acute or subacute
- •Severe COPD or lung disease requiring home oxygen use
- •Pregnancy
结局指标
主要结局
Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer
时间窗: 24 months
Determine the sensitivity and specificity of liquid biopsy and PET/CT in combination compared with PET/CT alone for predicting lung cancer for lesions 6 mm- 20 mm in size
次要结局
- ctDNA gene panel ability in detecting lung cancer(24 months)
- DNA methylation liquid biopsy ability in detecting lung cancer(24 months)
- Validate ML classifier for predicting lung cancer(30 months)
研究者
Rajesh Shah
Director of Interventional Radiology
Palo Alto Veterans Institute for Research