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

Not Applicable

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT05048810
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2020-02-06
• Study Start: 2020-02-07
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-17
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of diagnosis and staging	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.

Secondary Outcome Measures

Name	Time	Method
NTR-1 receptor expression by histology compared to tracer uptake	3 years	Pathological detection of NTR-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT/MR.
Safety and Tolerability Profile Measured by Adverse Events (AEs)	3 years	Safety and tolerability profile for the administration of 68Ga-DOTA-NT-20.3 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, China