Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, 68Ga, Claudin 18.2
Brief summary
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer
Interventions
Administration
Sponsors
SmartNuclide Biopharma
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 75 years (inclusive); 2. Possessing legal capacity, voluntarily participating in this clinical trial, and having signed the informed consent form (ICF); 3. Patients with a confirmed diagnosis of pancreatic cancer whose tumours are suitable for Claudin-18.2 testing; 4. Results of gastroscopy, CT, MRI or PET-CT scans performed within the past month (if available); 5. Pathology test results from within the past year;
Exclusion criteria
1. Patients with other clearly diagnosed malignant tumours; 2. Patients with uncontrolled severe infections, or those with other serious comorbidities; 3. Patients with a life expectancy of ≤3 months; 4. Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial; 5. Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety and tolerability profile of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer. | 1 week | Occurrence of AE/SAE according to CTCAE 5.0 |
| CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer. | 1 week | SUVmax of tumors |
Countries
China
Contacts
CONTACTDong Dai, Doctor
Outcome results
None listed