NCT07301814Recruiting
Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 56 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- NCT number
- NCT07301814
What you commit to
- Study type: Observational
- Planned participants: 56
- From 1 Sept 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital, China Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.