Clinical trial NCT05048810: Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma
Official title: Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of diagnosis and staging
timeFrame: 3 years
Secondary outcomes:
measure: NTR-1 receptor expression by histology compared to tracer uptake
timeFrame: 3 years
measure: Safety and Tolerability Profile Measured by Adverse Events (AEs)
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
Study officials:
affiliation: Nuclear Medicine Department, Nanjing First Hospital
name: Feng Wang, Ph.D
role: STUDY_DIRECTOR
References: