Non-Invasive Detection of Claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Standardized uptake value(SUV)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Outcomes
Primary Outcomes
Standardized uptake value(SUV)
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.
The expression level of Claudin-18.2
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.
Secondary Outcomes
- Progress free survival(3 years)
- Overall survival(3 years)
Investigators
Hu Jiajia
Nuclear Medicine
Ruijin Hospital