Pancreatic Ductal Adenocarcinoma
Conditions
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.
Interventions
RADIATION68Ga-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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of diagnosis and staging | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NTR-1 receptor expression by histology compared to tracer uptake | 3 years | Pathological detection of NTR-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT/MR. |
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | 3 years | 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). |
Countries
China
Outcome results
None listed