Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors

NCT07487883 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Observational

Started

2026-03-18

Last updated

2026-04-02

Condition(s) studied

Non-Small Cell Lung CancerMalignant NeoplasmPulmonary NodulesPET/CT

Investigational drug(s) / intervention(s)

PET/CT scans

PET/CT scans: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors. — up to 6 weeks
The diagnostic performance of 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT for initial staging will be evaluated and compared using histopathological findings or typical imaging features as reference standard.

Trial sites (1)

Facility	City	Region	Status
Peking University People's Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07487883 on ClinicalTrials.gov ↗ ← All trials in China