Non-Invasive Detection of claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Gastric Cancer, Gastroesophageal Junction Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-Invasive Detection of Claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
Overview
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.
Detailed description
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.
Primary outcome measures
- Standardized uptake value(SUV) [Time frame: Baseline and preoperative assessment at 3 weeks before surgery]
- The expression level of Claudin-18.2 [Time frame: Baseline and intraoperative specimen collection, assessment within 3 weeks postoperatively]
Secondary outcome measures (2)
- Progress free survival [Time frame: 3 years]
- Overall survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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.
- Aged 18-75 years old.
- Good general performance status with an expected overall survival of more than 6 months.
Exclusion criteria
- 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.
- Participants with poor compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine — Shanghai
Identifiers
NCT: NCT07554742 · RuijinH 2026-161