Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, China
NCT Number: NCT07554742
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Shanghai, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and preoperative assessment at 3 weeks before surgery
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.
Time frame: Baseline and intraoperative specimen collection, assessment within 3 weeks postoperatively
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.
Time frame: 3 years
Progress free survival
Time frame: 3 years
Overall survival
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
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