PET scan targeting CDH3 for lung tumors

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 novel PET probe, 68Ga-TOI-1, that binds Cadherin-3 (CDH3), a protein expressed on cancerous epithelial cells, to image lung tumors. Eligible adults with suspected or pathologically confirmed non-small cell lung cancer or pulmonary nodules will undergo PET/CT with the new tracer, and imaging findings will be compared to clinical, pathological, and standard imaging data. The probe has shown favorable affinity, selectivity, safety, and metabolic stability in preclinical work, and the study aims to define its diagnostic and staging performance across lung tumor types. Results will be used to determine whether CDH3-targeted PET can provide more precise preoperative evaluation and better differentiation between benign and malignant nodules.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years, male or female, with an ECOG performance status of 0 or 1;
2. Availability of complete clinical and imaging data;
3. Life expectancy ≥ 12 weeks;
4. Hematology, liver and kidney function meeting the following criteria: Hematology: WBC ≥ 4.0 × 10⁹/L or neutrophils ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN; Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT/AST ≤ 2.5 × ULN, ALP ≤ 2.5 × ULN; BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN;
5. Patients who have not received radiotherapy or chemotherapy and are eligible for surgical resection or biopsy to obtain a pathological diagnosis, or those highly suspected of having malignant pulmonary nodules according to clinical diagnostic criteria;
6. Pathologically confirmed lung cancer via biopsy before neoadjuvant therapy; life expectancy ≥ 12 weeks;
7. Ability to provide adequate tumor tissue for testing and research.

Exclusion Criteria:

1. Women who are planning pregnancy, pregnant, or breastfeeding;
2. History of other malignant tumors or prior receipt of other anti-tumor therapies;
3. Poor or missing PET scan image quality of the probe that fails to meet analysis standards;
4. Presence of claustrophobia or other mental illnesses;
5. Any other conditions deemed by the investigators as inappropriate for participation in this study.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xing Yang, MD — Peking University People's Hospital
• Study coordinator: Kezhong Chen, MD
• Email: mdkzchen@163.com
• Phone: +86-010-88325983

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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.