Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors

NCT07301814 | Recruiting

• 1 other identifier: XLan-0785
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The project aims to perform integrated PET/MR or PET/CT imaging in patients with histologically confirmed or clinically suspected gastric cancer, pancreatic cancer, cholangiocarcinoma, or other malignant tumors with high Claudin18.2 (CLDN18.2) expression, as well as healthy volunteers. This study utilizes a CLDN18.2-specific PET imaging probe (e.g., \[\^68Ga\]Ga-labeled humanized antibody fragment) to evaluate the feasibility, accuracy, and clinical value of non-invasive, in vivo CLDN18.2 visualization. For patients with malignant tumors, the study will assess the diagnostic performance of CLDN18.2-targeted PET in identifying tumor lesions, compare the imaging results with gold-standard histopathology, determine the location, extent, and metabolic features of CLDN18.2-positive lesions, and evaluate tumor burden and treatment stratification value compared with \[\^18F\]FDG PET imaging. These results may assist in patient selection for CLDN18.2-targeted therapies (e.g., Zolbetuximab), guide clinical decision-making, and provide early prediction of therapeutic response. For healthy volunteers, pharmacokinetic profiling will be conducted to investigate the biodistribution, clearance, and safety of the radiotracer in vivo.

Conditions

Gastric Cancer; Pancreatic Cancer; Cholangiocarcinoma Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Visual and standardized uptake values assessment of lesions and biodistribution

  At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of the tumor and organs will be measured after a semiquantitative analysis is performed for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting CLDN18.2 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or a higher stage.

  1 year

Secondary Outcomes (2)

• Radioactivity in the blood and urine samples

  1 year

• Pathological sections of tumour tissue

  1 year

Interventions

Specific PET imaging agents targeting CLDN18.2 DIAGNOSTIC_TEST

The project aims to perform integrated PET/MR or PET/CT imaging in patients with histologically confirmed or clinically suspected gastric cancer, pancreatic cancer, cholangiocarcinoma, or other malignant tumors with high Claudin18.2 (CLDN18.2) expression, as well as healthy volunteers. This study utilizes a CLDN18.2-specific PET imaging probe (e.g., \[\^68Ga\]Ga-labeled humanized antibody fragment) to evaluate the feasibility, accuracy, and clinical value of non-invasive, in vivo CLDN18.2 visualization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected or confirmed malignant tumors such as gastric adenocarcinoma, pancreatic cancer, bile duct cancer, esophageal adenocarcinoma, etc. (supporting evidence includes serum tumor markers, ultrasound, CT, MRI, and histopathological examination of tissue, etc.), and in good general condition.

You may qualify if:

• The participant or their legal representative is able to sign the informed consent form with signature and date;
• Commit to adhering to the research procedures and cooperating in the implementation of the entire research process;
• Adult patients or healthy volunteers (aged 18-70 years), male or female;
• Patients with malignant tumors such as gastric cancer, pancreatic cancer, bile duct cancer, esophageal cancer, etc., suspected or diagnosed clinically (supporting evidence includes serum tumor markers, ultrasound, CT, MRI, and other imaging data, as well as histopathological examination), and in good general condition;
• Meet specific laboratory test results;
• Women of childbearing age must use contraception for at least one month before screening and commit to using contraception throughout the study period and continuing it until the specified time after the study ends;

You may not qualify if:

• Those unable to complete PET/MR or PET/CT scans (including those unable to lie flat, claustrophobia, radiation phobia, etc.);
• Those with other comorbidities;
• Patients known to be allergic to the targeted CLDN18.2 PET imaging agent or synthetic excipients; fasting blood glucose level exceeding 11.0 mmol/L before injection of 18F-FDG;
• Those with a history of concomitant medication use;
• Patients considered to have poor compliance by the researcher.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital, China

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CN (1)