Non-Invasive Detection of claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging

NCT07554742 | Not Yet Recruiting

• 1 other identifier: RuijinH 2026-161
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Gastric Cancer; Gastroesophageal Junction Cancer

Keywords

claudin 18.2; PET/CT; pancreatic cancer; gastric cancer; gastroesophageal junction cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Progress free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible inpatients and outpatients from Ruijin Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

LI Biao

CONTACT

13661777388; lb10363@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 28, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)