PET scan targeting CDH3 for lung tumors

A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors

This will test whether a new PET imaging agent called 68Ga-TOI-1 that targets CDH3 can better detect and stage lung tumors and help tell malignant from benign pulmonary nodules in adults with suspected or confirmed non-small cell lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: chemotherapy, Immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07487883 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with ECOG 0–1 who have suspected malignant pulmonary nodules or pathologically confirmed lung cancer and who can undergo PET/CT and provide tumor tissue for testing are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have inadequate organ function, have recently received radiotherapy or chemotherapy, or cannot undergo PET/CT are unlikely to benefit from this imaging procedure.

Why it matters

Potential benefit: If successful, this imaging approach could improve detection and staging of lung cancer and reduce unnecessary biopsies or surgeries by better distinguishing benign from malignant nodules.

How similar studies have performed: Preclinical studies of CDH3-targeted probes have shown promising affinity and safety, but human clinical data are limited, making this an early clinical evaluation of the approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions: Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT, Pulmonary nodules