Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.