Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
NCT ID: NCT07301814
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
56 participants
OBSERVATIONAL
2025-09-01
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Interventions
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Specific PET imaging agents targeting CLDN18.2
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.
Eligibility Criteria
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Inclusion Criteria
2. Commit to adhering to the research procedures and cooperating in the implementation of the entire research process;
3. Adult patients or healthy volunteers (aged 18-70 years), male or female;
4. Patients with malignant tumors such as gastric cancer, pancreatic cancer, bile duct cancer, esophageal cancer, etc., suspected or diagnosed clinically (supporting evidence includes serum tumor markers, ultrasound, CT, MRI, and other imaging data, as well as histopathological examination), and in good general condition;
5. Meet specific laboratory test results;
6. Women of childbearing age must use contraception for at least one month before screening and commit to using contraception throughout the study period and continuing it until the specified time after the study ends;
Exclusion Criteria
2. Those with other comorbidities;
3. Patients known to be allergic to the targeted CLDN18.2 PET imaging agent or synthetic excipients; fasting blood glucose level exceeding 11.0 mmol/L before injection of 18F-FDG;
4. Those with a history of concomitant medication use;
5. Patients considered to have poor compliance by the researcher.
18 Years
ALL
Yes
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Xiaoli Lan, PhD
Role: STUDY_DIRECTOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Wuhan Union Hospital, China
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoli Lan, PhD
Role: primary
Other Identifiers
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XLan-0785
Identifier Type: -
Identifier Source: org_study_id