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The purpose of this study is to use Claudin 18.2 (CLDN18.2)-targeted positron emission tomography (PET) imaging technology to evaluate its detection efficacy and diagnostic threshold for CLDN18.2-positive pancreatic cancer and gastric/gastroesophageal junction cancer, analyze the quantitative value of PET parameters in CLDN18.2 expression and their correlation with prognosis, and provide a basis for the precise selection of CLDN18.2-targeted therapy.
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. One or two [68Ga]Ga-NODAGA-SNA014 PET scans will be performed according to disease stage and treatment plan. CLDN18.2 expression will be assessed by immunohistochemistry (IHC) in surgical specimens. The optimal SUV threshold and PET quantification potential for CLDN18.2 expression will be evaluated in comparison with histopathology, along with their correlation with prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants with pancreatic cancer, gastric cancer or GEJ cancer and CLDN18.2 expression | Participants with pancreatic cancer, gastric cancer or gastroesophageal junction (GEJ) cancer and immunohistochemistry (IHC)-confirmed CLDN18.2 expression at any level. |
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| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value(SUV) | Participants include treatment-naive patients with upfront resectable disease, those becoming resectable after neoadjuvant or conversion therapy, and patients with recurrent disease that is either resectable or becomes resectable following treatment. One or two [68Ga]Ga-NODAGA-SNA014 positron emission tomography (PET) scans will be performed according to disease stage and treatment strategy, with claudin18.2 immunohistochemistry to be conducted on surgical specimens. Upfront resectable patients will undergo one preoperative scan, while patients requiring treatment prior to resection will receive one scan before treatment and an additional scan before surgery. The SUV values of tumor lesions will be measured on PET images. | Baseline and preoperative assessment at 3 weeks before surgery |
| The expression level of Claudin-18.2 | Histopathologically confirmed pancreatic cancer or gastric/gastroesophageal junction cancer with any level of claudin 18.2 expression confirmed by immunohistochemistry (IHC) before enrollment. Claudin 18.2 expression will be further analyzed by IHC in surgical specimens. | Baseline and intraoperative specimen collection, assessment within 3 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival | Progress free survival | 3 years |
| Overall survival | Overall survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible inpatients and outpatients from Ruijin Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LI Biao | Contact | 13661777388 | lb10363@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine | Shanghai | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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