TheranosticTrials.org

Clinical Trial · NCT07487883

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

Overview

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.

Sponsor

Peking University First Hospital

Contacts

Jun Wang, M.M. (STUDY_CHAIR)

Kezhong Chen, MD (STUDY_DIRECTOR)

Xing Yang, MD (PRINCIPAL_INVESTIGATOR)

Hao Li, MD (PRINCIPAL_INVESTIGATOR)

Kezhong Chen, MD (CONTACT)

mdkzchen@163.com

+86-010-88325983

Yutao Li, MD (CONTACT)

liyutao@bjmu.edu.cn

+86-010-88325754

Yuan Li, MD (PRINCIPAL_INVESTIGATOR)

Ziqian Bai, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07487883

Drug / Compound

TOI-1

Isotope(s):
Target(s):
  • CDH3

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Availability of complete clinical and imaging data;
  • 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;
  • Life expectancy ≥ 12 weeks;
  • 1. Age ≥ 18 years, male or female, with an ECOG performance status of 0 or 1;
  • 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;

Exclusion

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