Clinical Study of GPA33-specific PET/CT for the Diagnosis of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT.
研究概览
简要总结
In this study, we will first investigate the imaging safety and feasibility of [68Ga]Ga-NOTA-WWH347 and [18F]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. The second goal of the study is to preliminarily investigate the diagnostic efficacy (e.g., sensitivity and specificity) of [68Ga]Ga-NOTA-WWH347 and [18F]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. This study will provide a new method for the noninvasive target-specific diagnosis of colorectal cancer, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 65 years of age and of either sex.
- •Patients with colorectal cancer confirmed by puncture or surgical pathology.
- •Written informed consent signed by the subject or legal guardian or caregiver.
- •Willingness and ability to cooperate with all programs of this study.
排除标准
- •Severe hepatic or renal insufficiency;
- •Targeted therapy before radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
- •Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- •History of serious surgery in the last month.
- •Those who have participated in other clinical trials during the same period.
研究组 & 干预措施
patients with colorectal cancer
Subjects were recruited from the Department of Gastroenterology, Huashan Hospital, Fudan University, Shanghai, China.
干预措施: [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 (Radiation)
结局指标
主要结局
Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT.
时间窗: 90mins from time of injection
To assess the safety, sensitivity and specificity of diagnosing colorectal cancer using \[68Ga\]Ga-NOTA-WWH347 or \[18F\]F-H3RESCA-WWH347 PET/CT.
次要结局
未报告次要终点