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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    6
  • sponsor
    Nanjing First Hospital, Nanjing Medical University
Updated on 25 September 2021

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).

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.

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment 68Ga-DOTA-NT-20.3
Clinical Study IdentifierNCT05048810
SponsorNanjing First Hospital, Nanjing Medical University
Last Modified on25 September 2021

Eligibility

Yes No Not Sure

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
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