Cholangiocarcinoma Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer
Conditions
Brief summary
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_TESTSpecific 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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Each participant must meet all inclusion criteria to be eligible to participate in the study: 1. The participant or their legal representative is able to sign the informed consent form with signature and date; 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; 7. Other set inclusion criteria.
Exclusion criteria
* All subjects who meet any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual and standardized uptake values assessment of lesions and biodistribution | 1 year | At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of the tumor and organs will be measured after a semiquantitative analysis is performed for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting CLDN18.2 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or a higher stage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radioactivity in the blood and urine samples | 1 year | Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection. |
| Pathological sections of tumour tissue | 1 year | The excised tumour tissue was taken for immunohistochemistry to verify its CLDN18.2 expression |
Countries
China
Contacts
Primary ContactXiaoli Lan, PhD
Outcome results
None listed