Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of diagnosis and staging
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with pancreatic ductal adenocarcinoma (PDAC).
详细描述
This study is design to prospectively investigate the safety and efficacy of 68Ga-DOTA-NT-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with PDAC. Neurotensin receptor 1 (NTR-1) is the high affinity receptor of Neurotensin (NT), which was found abnormal expression in the early stages of PDAC malignant cell transformation. 68Ga-DOTA-NT-20.3 as a new NTR-1 targeted probe was prepared and showed good uptake on PDAC cell line and animal studies. The study intends to recruit 6 PDAC volunteers to participate in the experiment. Patients were evaluated with 18F-fluorodeoxyglucose (18F-FDG). And then all patients underwent a single-injection with 68Ga-DOTA-NT-20.3, dual-modality imaging protocol consisting of a PET/CT and subsequent PET/MR scan. The follow-up period was followed up to assess safety and effectiveness.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with pathohistologically proven localized or metastatic PDAC;
- •patient aged 18 or older, male or female, who can provide written informed consent for this study;
- •patient with complete clinical data.
排除标准
- •patient age < 18 years;
- •patient with other active cancer;
- •patient with PDAC under the treatment blocking NT receptors;
- •pregnant or lactating women;
- •patient who cannot stay on PET/CT camera for app. 90 minutes;
- •patient who cannot stand MRI;
- •patient simultaneously participating in another clinical trial;
- •patient with HIV, HCV, HVB infection or other serious chronic infection
- •patient with serious mental, neurological, cardiovascular, respiratory and other system diseases;
- •patient with liver and kidney function (GFR less than 50 ml/min) disease;
- •patient with severe severe refractory mental disorder.
研究组 & 干预措施
68Ga-DOTA-NT-20.3
Subjects will undergo PET imaging using 68Ga-DOTA-NT-20.3.
干预措施: 68Ga-DOTA-NT-20.3 (Radiation)
结局指标
主要结局
Sensitivity and specificity of diagnosis and staging
时间窗: 3 years
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The signal intensity of PET indicates the presence and density of NTR-1 in the tissue. The lesion intake is higher than the liver and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, and calculate the T/B ratio.
次要结局
- NTR-1 receptor expression by histology compared to tracer uptake(3 years)
- Safety and Tolerability Profile Measured by Adverse Events (AEs)(3 years)
研究者
FengWang
Director of nuclear medicine department
Nanjing First Hospital, Nanjing Medical University