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

NCT07487883 | Recruiting

• 1 other identifier: 92259303
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer; Malignant Neoplasm; PET/CT; Pulmonary Nodules

Keywords

Malignant Neoplasm; PET/CT; Non-Small Cell Lung Cancer; Pulmonary nodules

Outcome Measures

Primary Outcomes (1)

• The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors.

  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.

  up to 6 weeks

Secondary Outcomes (4)

• Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT

  up to 6 weeks

• Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT

  up to 6 weeks

• Correlation between 68Ga-TOI-1 SUVmax and CDH3 H-score in Tumor Tissue

  up to 6 weeks

• Correlation between 68Ga-TOI-1 SUVmean and CDH3 H-score in Tumor Tissue

  up to 6 weeks

Study Arms (1)

CDH3-targeted PET in lung malignant tumors

Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-CDH3 PET/CT scans within 1 week.

Diagnostic Test: PET/CT scans

Interventions

PET/CT scans DIAGNOSTIC_TEST

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.

CDH3-targeted PET in lung malignant tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This single-center, prospective, single-arm study plans to enroll 30 patients with lung cancer receiving neoadjuvant immunochemotherapy and 50 patients with pulmonary nodules highly suspected of malignancy based on clinical diagnostic criteria who are scheduled to undergo wedge resection or anatomic lobectomy/sublobar resection.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (5)

• Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3.

  PMID: 37019717 BACKGROUND

• Kennedy GT, Azari FS, Bernstein E, Marfatia I, Din A, Kucharczuk JC, Low PS, Singhal S. Targeted Intraoperative Molecular Imaging for Localizing Nonpalpable Tumors and Quantifying Resection Margin Distances. JAMA Surg. 2021 Nov 1;156(11):1043-1050. doi: 10.1001/jamasurg.2021.3757.

  PMID: 34431971 BACKGROUND

• Gangadharan S, Sarkaria IN, Rice D, Murthy S, Braun J, Kucharczuk J, Predina J, Singhal S. Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer. Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19.

  PMID: 33221195 BACKGROUND

• Chen K, Yang F, Shen H, Wang C, Li X, Chervova O, Wu S, Qiu F, Peng D, Zhu X, Chuai S, Beck S, Kanu N, Carbone D, Zhang Z, Wang J. Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer. Cancer Cell. 2023 Oct 9;41(10):1749-1762.e6. doi: 10.1016/j.ccell.2023.08.010. Epub 2023 Sep 7.

  PMID: 37683638 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Multiple Pulmonary Nodules

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kezhong Chen, MD

  Peking University People's Hospital

  STUDY DIRECTOR

• Jun Wang, M.M.

  Peking University People's Hospital

  STUDY CHAIR

• Xing Yang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Yuan Li, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Hao Li, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Ziqian Bai, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kezhong Chen, MD

CONTACT

+86-010-88325983; mdkzchen@163.com

Yutao Li, MD

CONTACT

+86-010-88325754; liyutao@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Thoracic Oncology Institute

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 23, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)