PET imaging that targets CLDN18.2 to find stomach, pancreatic, bile-duct, and esophageal cancers

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

This project will try a CLDN18.2-targeted PET scan in adults with suspected or confirmed gastric, pancreatic, bile-duct, or esophageal cancer (and some healthy volunteers) to see if it can show CLDN18.2-positive tumors.

Quick facts

• Study type: Observational
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: radiation, Zolbetuximab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07301814 on ClinicalTrials.gov

What this trial studies

This observational study uses a CLDN18.2-specific PET probe (for example a 68Ga-labeled humanized antibody fragment) combined with PET/CT or PET/MR to image adults with histologically confirmed or clinically suspected gastric, pancreatic, bile-duct, or esophageal cancers and healthy volunteers. Imaging results will be compared with histopathology and standard [18F]FDG PET to measure diagnostic performance, lesion location, extent, and metabolic features. The study will quantify tumor burden and explore whether CLDN18.2 PET can help select patients for CLDN18.2-targeted therapies such as Zolbetuximab. Primary outcomes focus on the feasibility, accuracy, and clinical value of noninvasive in vivo CLDN18.2 visualization.

Who should consider this trial

Good fit: Adults aged 18–70 with suspected or confirmed gastric, pancreatic, bile-duct, or esophageal cancer in good general condition, or healthy volunteers, who can give informed consent and meet laboratory criteria.

Not a fit: Patients whose tumors do not express CLDN18.2, those outside the 18–70 age range, or anyone with contraindications to PET imaging are unlikely to benefit.

Why it matters

Potential benefit: If successful, this scan could noninvasively identify tumors that express CLDN18.2 and help match patients to CLDN18.2-targeted treatments like Zolbetuximab.

How similar studies have performed: Early preclinical and first-in-human imaging work targeting CLDN18.2 and clinical trials of CLDN18.2-directed therapies have shown promise, but CLDN18.2 PET imaging remains novel and not yet widely validated.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital, China — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaoli Lan, PhD

Conditions Gastric Cancer; Pancreatic Cancer; Cholangiocarcinoma Cancer; Esophageal Cancer