Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Specific PET imaging agents targeting CLDN18.2.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Pancreatic Cancer, Cholangiocarcinoma Cancer, Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 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 visual
Primary outcome measures
- Visual and standardized uptake values assessment of lesions and biodistribution [Time frame: 1 year]
Secondary outcome measures (2)
- Radioactivity in the blood and urine samples [Time frame: 1 year]
- Pathological sections of tumour tissue [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Each participant must meet all inclusion criteria to be eligible to participate in the study:
- The participant or their legal representative is able to sign the informed consent form with signature and date;
- Commit to adhering to the research procedures and cooperating in the implementation of the entire research process;
- Adult patients or healthy volunteers (aged 18-70 years), male or female;
- 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;
- Meet specific laboratory test results;
- 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;
- Other set inclusion criteria.
Exclusion criteria
- All subjects who meet any exclusion criteria baseline will be excluded from the study:
- Those unable to complete PET/MR or PET/CT scans (including those unable to lie flat, claustrophobia, radiation phobia, etc.);
- Those with other comorbidities;
- 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;
- Those with a history of concomitant medication use;
- Patients considered to have poor compliance by the researcher.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Wuhan Union Hospital, China — Wuhan
Identifiers
NCT: NCT07301814 · XLan-0785