Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors (NCT07487883) | Clinical Trial Compass
RecruitingNot Applicable
Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors
China80 participantsStarted 2026-03-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Women who are planning pregnancy, pregnant, or breastfeeding;
What they're measuring
1
The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors.