68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer. — 1 week SUVmean of tumors
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer. — 1 week Correlation of tumor uptakes and Immunohistochemistry
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute and Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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