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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wuhan Union Hospital, China
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xiaoli Lan, PhD
• Email: lxl730724@hotmail.com
• Phone: 0086-027-83692633

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prehabilitation before high-risk cancer surgery

  This trial tests a multidisciplinary prehabilitation program to see if it helps adults with cancer recover better after major abdominal surgery.

  Recruiting Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07638410

• Virtual exercise program to preserve function and prevent disability during chemotherapy

  This trial tests whether supervised resistance sessions by video plus short home aerobic workouts help adults 18–64 maintain strength and stay active while receiving curative-intent chemotherapy.

  Recruiting at 29 sites Alliance for Clinical Trials in Oncology · Dublin, California and 29 other locations · NCT07059884

• IDOV-Immune for advanced solid tumors

  This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

  Recruiting at 5 sites Phase 1 ViroMissile, Inc. · St Louis, Missouri and 4 other locations · NCT06910657

• Evaluating zanidatamab for HER2-expressing tumors

  This study is testing a new drug called zanidatamab to see if it can help people with certain types of cancer that have high levels of HER2 and who have already tried other treatments without success.

  Recruiting at 30 sites Phase 2 Jazz Pharmaceuticals · Prescott, Arizona and 41 other locations · NCT06695845

• Evaluating BL-M17D1 for HER2 Positive Gastrointestinal Cancer

  This study is testing a new drug called BL-M17D1 to see if it is safe and effective for people with advanced HER2 positive gastrointestinal cancer and other solid tumors.

  Recruiting Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong · NCT06500052

• Using 64Cu-LNTH-1363S for imaging in patients with sarcoma or gastrointestinal cancers

  This study is testing a new imaging agent called 64Cu-LNTH-1363S in patients with metastatic sarcoma or gastrointestinal cancers to see how safe it is and how well it works for imaging their tumors.

  Recruiting at 5 sites Phase 1/2 Lantheus Medical Imaging · Duarte, California and 4 other locations · NCT06298916

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.