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

NCT05048810 | Completed

• 1 other identifier: 68Ga-DOTA-NT-20.3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NTR-1 receptor expression by histology compared to tracer uptake

  3 years

• Safety and Tolerability Profile Measured by Adverse Events (AEs)

  3 years

Study Arms (1)

68Ga-DOTA-NT-20.3

EXPERIMENTAL

Subjects will undergo PET imaging using 68Ga-DOTA-NT-20.3.

Radiation: 68Ga-DOTA-NT-20.3

Interventions

68Ga-DOTA-NT-20.3 RADIATION

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.

68Ga-DOTA-NT-20.3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, China

Location

Study Officials

• Feng Wang, Ph.D

  Nuclear Medicine Department, Nanjing First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of nuclear medicine department

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: September 17, 2021
• Study Start: February 7, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

CN (1)