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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048810
• Other study ID #: 68Ga-DOTA-NT-20.3
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Radiation:
• 68Ga-DOTA-NT-20.3
In this study, all patients will receive one injection of 68Ga-DOTA-NT-20.3, a PET radiopharmaceutical selective for neurotensin receptor 1 (NTR-1). For the injection, subjects will receive a target dose of 2-4 MBq per kg of body weight as a bolus injection. 68Ga-DOTA-NT-20.3 injection will be followed by a 10 ml saline flush.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of diagnosis and staging	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.	3 years
Secondary	NTR-1 receptor expression by histology compared to tracer uptake	Pathological detection of NTR-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT/MR.	3 years
Secondary	Safety and Tolerability Profile Measured by Adverse Events (AEs)	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).	3 years