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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Pancreatic Cancer; Esophageal Cancer; Cholangiocarcinoma Cancer
• Intervention / Treatment: Diagnostic test: Specific PET imaging agents targeting CLDN18.2

• Study Type: Observational
• Enrollment (Estimated): 56

Contacts and Locations

• Study Contact: Name: Xiaoli Lan, PhD; Phone Number: 0086-027-83692633; Email: lxl730724@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Wuhan Union Hospital, China
      • Contact: Xiaoli Lan, PhD; Phone Number: +86-027-83692633; Email: lxl730724@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• Each participant must meet all inclusion criteria to be eligible to participate in the study:

  1. The participant or their legal representative is able to sign the informed consent form with signature and date;
  2. Commit to adhering to the research procedures and cooperating in the implementation of the entire research process;
  3. Adult patients or healthy volunteers (aged 18-70 years), male or female;
  4. 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;
  5. Meet specific laboratory test results;
  6. 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;
  7. Other set inclusion criteria.

Exclusion Criteria:

• All subjects who meet any exclusion criteria baseline will be excluded from the study:

  1. Those unable to complete PET/MR or PET/CT scans (including those unable to lie flat, claustrophobia, radiation phobia, etc.);
  2. Those with other comorbidities;
  3. 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;
  4. Those with a history of concomitant medication use;
  5. Patients considered to have poor compliance by the researcher.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radioactivity in the blood and urine samples	Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection.	1 year
Pathological sections of tumour tissue	The excised tumour tissue was taken for immunohistochemistry to verify its CLDN18.2 expression	1 year

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Study Director: Xiaoli Lan, PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Pancreatic Diseases; Esophageal Diseases; Stomach Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: XLan-0785

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No