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

Nanjing Medical University

Status

Completed

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Radiation: 68Ga-DOTA-NT-20.3

Study type

Interventional

Funder types

Other

Identifiers

NCT05048810

68Ga-DOTA-NT-20.3

Details and patient eligibility

About

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).

Full description

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.

Enrollment

6 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.