Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors
A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors
Peking University People's Hospital
80 participants
Mar 18, 2026
OBSERVATIONAL
Conditions
Summary
Lung malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. CDH3 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous epithelial cells. A new PET probe, 68Ga-TOI-1, targeting CDH3 has been developed with better affinity and selectivity than previous probes. Preclinical data support its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of lung tumors, providing a new and precise evaluation method for lung malignant tumors.
Eligibility
Inclusion Criteria7
- Age ≥ 18 years, male or female, with an ECOG performance status of 0 or 1;
- Availability of complete clinical and imaging data;
- Life expectancy ≥ 12 weeks;
- 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;
- 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;
- Pathologically confirmed lung cancer via biopsy before neoadjuvant therapy; life expectancy ≥ 12 weeks;
- Ability to provide adequate tumor tissue for testing and research.
Exclusion Criteria5
- Women who are planning pregnancy, pregnant, or breastfeeding;
- History of other malignant tumors or prior receipt of other anti-tumor therapies;
- Poor or missing PET scan image quality of the probe that fails to meet analysis standards;
- Presence of claustrophobia or other mental illnesses;
- Any other conditions deemed by the investigators as inappropriate for participation in this study.
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Interventions
PET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisition is 60 minutes. Processing of PET dynamic scan data: Dynamic PET images are divided into 2-minute intervals to obtain time-activity curves by extracting the radioactivity within regions of interest at different time points, reflecting tracer uptake and enabling calculation of the time to peak. Multi-modality imaging data are analyzed by radiologists with over 10 years of experience in diagnosing respiratory diseases.
Locations(1)
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NCT07487883