XCancer

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

Description:

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.

Sponsor:

Norwegian University of Science and Technology

Contacts:

Xiaoli Lan, PhD (STUDY_DIRECTOR)

Xiaoli Lan, PhD (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

Government Study Link:

NCT07301814 - Click here to see study on

ClinicalTrials.gov

Ga-labeled humanized antibody fragment targeting CLDN18.2

Isotope(s):
Target(s):
  • Claudin 18.2
Ligand Class: Small Proteins and Antibody Fragments

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules
Inclusion
  • 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;
  • * Each participant must meet all inclusion criteria to be eligible to participate in the study:
  • Commit to adhering to the research procedures and cooperating in the implementation of the entire research process;
  • The participant or their legal representative is able to sign the informed consent form with signature and date;
  • Adult patients or healthy volunteers (aged 18-70 years), male or female;
Exclusion
  • Those with other comorbidities;
  • Those unable to complete PET/MR or PET/CT scans (including those unable to lie flat, claustrophobia, radiation phobia, etc.);
  • 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;
  • * All subjects who meet any exclusion criteria baseline will be excluded from the study: