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.
Participants with histopathologically confirmed pancreatic cancer and gastric/gastroesophageal junction cancer with claudin 18.2 expression of any level, including treatment-naive patients with upfront resectable disease, patients with post-operative recurrent disease who are or become resectable following treatment, and patients rendered resectable after neoadjuvant or conversion therapy.
Signed and dated informed consent form.
Commitment to comply with research procedures and co-operation in the implementation of the full research process.
Male or female participants.
Participants with prior Claudin 18.2 targeted therapy.
Participants with concurrent other active malignancies.
Participants with severe medical conditions that render them unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
Pregnant women and women who may be pregnant, women who are breastfeeding.
Eligible inpatients and outpatients from Ruijin Hospital
Other
Prospective
Not listed
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.
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.
Progress free survival
Progress free survival
Overall survival
Overall survival
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