Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
研究概览
简要总结
In this study, we will investigate the diagnostic efficacy and safety of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide 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
- Non Randomized
- 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
- •(1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.
- •(3) Written informed consent signed by the subject or his/her legal guardian or caregiver.
- •(4) Willingness and ability to cooperate with all programs of this study.
排除标准
- •- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)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.
- •(4) History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.
研究组 & 干预措施
patients with gastric cancer
Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
干预措施: [18F]F-H3RESCA-3A12 及[68Ga]Ga-NOTA-3A12 (Radiation)
patients with pancreatic cancer
Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
干预措施: [18F]F-H3RESCA-3A12 及[68Ga]Ga-NOTA-3A12 (Radiation)
结局指标
主要结局
To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
时间窗: 90mins from time of injection
In this study, we will first investigate the safety and feasibility of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers. The secondary goal of the clinical trial is to preliminary assess the sensitivity and specificity of using \[18F\]F-H3RESCA-3A12 or \[68Ga\]Ga-NOTA-3A12 PET/CT imaging for the diagnosis of metastatic gastric or pancreatic cancers.
次要结局
未报告次要终点
研究者
YiHui Guan
Professor
Huashan Hospital