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Clinical Trial Summary

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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05048810
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact
Status Completed
Phase N/A
Start date February 7, 2020
Completion date March 1, 2023

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