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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of integrated PET/MR or PET/CT imaging to detect Claudin18.2 (CLDN18.2) in patients with confirmed or suspected malignant tumors such as gastric cancer, pancreatic cancer, cholangiocarcinoma, and esophageal cancer, as well as in healthy volunteers. The aim is to evaluate the feasibility, accuracy, and clinical value of a CLDN18.2-specific PET imaging probe for non-invasive visualization of these tumors. This research also explores how this imaging might help in selecting patients for CLDN18.2-targeted therapies and guide treatment decisions. The study uses a CLDN18.2-targeted PET imaging agent, such as a [68Ga]Ga-labeled humanized antibody fragment, to perform scans on eligible patients and healthy volunteers. Imaging includes PET/MR or PET/CT methods to identify tumor lesions, assess their location, extent, and metabolic characteristics, and compare findings with standard histopathology and [18F]FDG PET imaging. For healthy volunteers, the study will also analyze how the radiotracer distributes and clears in the body. Participants will undergo imaging scans and provide biological samples such as blood and urine for analysis during the study. Researchers will assess visual and standardized uptake values of lesions and biodistribution over one year. Tumor tissue pathology will be examined, and radiotracer radioactivity in samples will be monitored. The study aims to provide detailed diagnostic information and evaluate the radiotracer's safety and behavior in the body throughout the observation period.
CONDITIONS
Brief 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 with signature and date
- Willing to follow all research procedures throughout the study
- Adults aged 18 to 70 years, male or female
- Patients with suspected or diagnosed gastric, pancreatic, bile duct, or esophageal cancer in good general condition
- Meet specific laboratory test requirements
- Women of childbearing age must use contraception from one month before screening through the study period
- Other specified inclusion criteria
You will not qualify if you...
- Unable to complete PET/MR or PET/CT scans (e.g., cannot lie flat, claustrophobia, radiation phobia)
- Presence of other significant medical conditions
- Known allergy to the CLDN18.2 PET imaging agent or its components
- Fasting blood glucose level above 11.0 mmol/L before 18F-FDG injection
- History of using interfering medications
- Poor compliance as judged by the researcher
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants undergo PET/MR or PET/CT imaging using a CLDN18.2-specific PET imaging probe to visualize malignant tumors and assess biodistribution.
Imaging sessions and sample collections over 1 year
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital, China
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
X
Xiaoli Lan, PhD
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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