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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Radiation: 68Ga-DOTA-NT-20.3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTA-NT-20.3<br>Subjects will undergo PET imaging using 68Ga-DOTA-NT-20.3. | Radiation: 68Ga-DOTA-NT-20.3<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |