Actively Recruiting
Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-12-24
56
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The project aims to perform integrated PET/MR or PET/CT imaging in patients with histologically confirmed or clinically suspected gastric cancer, pancreatic cancer, cholangiocarcinoma, or other malignant tumors with high Claudin18.2 (CLDN18.2) expression, as well as healthy volunteers. This study utilizes a CLDN18.2-specific PET imaging probe (e.g., \[\^68Ga\]Ga-labeled humanized antibody fragment) to evaluate the feasibility, accuracy, and clinical value of non-invasive, in vivo CLDN18.2 visualization. For patients with malignant tumors, the study will assess the diagnostic performance of CLDN18.2-targeted PET in identifying tumor lesions, compare the imaging results with gold-standard histopathology, determine the location, extent, and metabolic features of CLDN18.2-positive lesions, and evaluate tumor burden and treatment stratification value compared with \[\^18F\]FDG PET imaging. These results may assist in patient selection for CLDN18.2-targeted therapies (e.g., Zolbetuximab), guide clinical decision-making, and provide early prediction of therapeutic response. For healthy volunteers, pharmacokinetic profiling will be conducted to investigate the biodistribution, clearance, and safety of the radiotracer in vivo.
CONDITIONS
Official Title
Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent form with signature and date
- Willing to follow study procedures and cooperate throughout the research process
- Adults aged 18 to 70 years, male or female
- Patients with suspected or confirmed malignant tumors such as gastric cancer, pancreatic cancer, bile duct cancer, or esophageal cancer, supported by clinical evidence
- Meet specific laboratory test requirements
- Women of childbearing age must use contraception one month before screening and continue throughout the study and specified time after
- Other inclusion criteria as set by the study
You will not qualify if you...
- Unable to complete PET/MR or PET/CT scans (e.g., inability to lie flat, claustrophobia, radiation fear)
- Presence of other significant medical conditions
- Known allergy to the CLDN18.2 PET imaging agent or its components
- Fasting blood glucose higher than 11.0 mmol/L before 18F-FDG injection
- History of using concomitant medications
- Considered likely to have poor compliance by the researcher
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital, China
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
X
Xiaoli Lan, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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