The Role of 18F-FDG and 68Ga-FAPI PET/CT in the Diagnosis and the Efficacy Evaluation of Advanced Colorectal Cancer (peritoneal Metastasis With/without Other Metastases)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This study aims to investigate the value of 18F-FDG and 68Ga-FAPI PET/CT in evaluating the outcome of conversion therapy and the prognosis of advanced colorectal cancer (peritoneal metastasis with/without other metastases)
详细描述
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 18F-FDG and 68Ga-FAPI PET/CT at baseline and after 3 months of conversion therapy. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colorectal cancer, clinical or other imaging suspicion of peritoneal metastasis with or without other distant metastases.
- •Patients voluntarily enrolled in this study by signing an informed consent form
- •Age ≥ 18 years
- •Expected life expectancy ≥ 3 months
- •Adequate organ and bone marrow function
- •Willingness to adhere to the study protocol and follow-up programme
排除标准
- •Pregnant or breastfeeding women.
- •Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix
- •Severe mental disease, uncontrolled epilepsy, or central nervous system disease
- •Subjects with current concurrent interstitial pneumonitis or interstitial lung disease, or subjects with previous interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or subjects with other conditions that may interfere with the judgement and management of immune-related pulmonary toxicity, e.g., pulmonary fibrosis, organising pneumonia (e.g., occlusive bronchiectasis), pulmonary fibrosis, organising pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, Drug-associated pneumonia, idiopathic pneumonia, active pneumonia, or severe pulmonary impairment on CT; and active tuberculosis
结局指标
主要结局
Diagnostic accuracy
时间窗: Baseline and up to 3 months
18F-FDG and 68Ga-FAPI PET/CT was used to diagnose the lesions of the patients, and the diagnostic performance of PET/CT was evaluated by comparing the diagnostic results with the pathological results/clinical evaluation results.
Standardized uptake value(SUV)
时间窗: Baseline and up to 3 months
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for tumor lesions
Target-to-background ratio(TBR)
时间窗: Baseline and up to 3 months
68Ga-FAPI and 18F-FDG uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.
次要结局
- Progress free survival(3 years)
- Overall survival(3 years)