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

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).

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Radiation: 68Ga-DOTA-NT-20.3

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-DOTA-NT-20.3; Subjects will undergo PET imaging using 68Ga-DOTA-NT-20.3.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: Feng Wang, Ph.D, Nuclear Medicine Department, Nanjing First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 68Ga-DOTA-NT-20.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No