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Non-Small Cell Lung CancerNCT07487883

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

An observational study of Non-Small Cell Lung Cancer and Malignant Neoplasm, run by Peking University People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET/CT scans
Type of treatment
Injection or infusion
How many people
80 participants
Where
1 siteChina
Study dates
18 Mar 2026to 30 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Kezhong Chen, MD, +86-010-88325983, mdkzchen@163.com

    Yutao Li, MD, +86-010-88325754, liyutao@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors

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.

Read the detailed description

Cancer is a leading cause of high mortality rates worldwide and a significant barrier to increasing life expectancy. Among various cancer types, lung cancer is one of the most common malignant tumors globally. According to global cancer statistics, as of 2020, the global incidence rate of lung cancer was 11.4%, and the mortality rate was 18%. Lung cancer is a major cause of cancer-related deaths in China and worldwide, particularly non-small cell lung cancer (NSCLC), and its treatment strategies are continuously evolving. Immunotherapy and targeted neoadjuvant therapy can help eliminate micrometastases to reduce postoperative recurrence, lower tumor staging to improve the resectability of primary lesions, and enhance the long-term survival rate of lung cancer patients to some extent. However, for patients with resectable lung cancer, surgery remains the primary curative approach.

Given the significant individual variability in lung cancer treatment outcomes, the suboptimal efficacy of traditional PET in monitoring treatment response, and the lack of effective methods for distinguishing benign from malignant pulmonary nodules, there is a critical clinical need for innovative approaches. Leveraging key molecular imaging markers for preoperative assessment of treatment efficacy and assisting in the differentiation of benign and malignant pulmonary nodules is a crucial scientific direction for our research team.

In recent years, molecular imaging has been increasingly applied in cancer diagnosis and treatment, with PET molecular imaging emerging as a key tool for lung cancer management. By utilizing targeting moieties of molecular probes to precisely bind to tumor biomarkers, coupled with radiation emitted from radionuclides during decay, it is possible to achieve accurate lesion detection and non-invasive monitoring. This approach holds promise for overcoming longstanding challenges in conventional PET imaging for comprehensive lung cancer treatment, such as high false-positive rates.

High-dimensional multi-omics technologies integrate data from genomics, transcriptomics, proteomics, and other levels. By employing transcriptomics and proteomics, overexpressed proteins in lung cancer tissues can be identified at the tissue level, while spatial transcriptomics and single-cell transcriptomics can validate the cellular localization of target proteins. Multi-omics approaches enable systematic exploration of key molecular targets in lung cancer, providing a reliable pathway for precision target discovery. Utilizing a previously established large-scale Chinese multi-omics lung cancer cohort, combined with bioinformatics analysis and in vitro and in vivo molecular biology validation, the investigators identified CDH3 as a surface biomarker for non-small cell lung cancer.

Cadherin-3 (CDH3) is a glycoprotein whose abnormal high expression in non-small cell lung cancer is closely associated with poor prognosis, enhanced tumor proliferation and migration, and the formation of an immunosuppressive microenvironment. CDH3 has emerged as a promising novel therapeutic target for lung cancer. Currently, drug development targeting CDH3 primarily focuses on antibody-drug conjugates (ADCs). In a study involving five patients with advanced NSCLC harboring EGFR mutations, these drugs achieved an objective response rate as high as 80%. Through multi-omics imaging target screening, CDH3 was identified as a potential imaging target due to its specific high expression on the surface of lung cancer cells.

Supported by a key project from the National Natural Science Foundation of China, our team has previously developed a CDH3-targeted molecular probe, TOI-1, with independent intellectual property rights and has applied for a patent (published under publication number CN121426959A). This probe has demonstrated excellent sensitivity and specificity in preclinical animal models. the investigators are now collaborating with the Department of Nuclear Medicine at our hospital to conduct an exploratory clinical study on the 68Ga-TOI-1 PET molecular probe. 68Ga-TOI-1 PET/CT imaging is expected to help determine the benign or malignant nature of tumors and their extent of involvement, enable tumor localization and qualitative diagnosis, facilitate early diagnosis and restaging of recurrent tumors, and provide scientific evidence for disease staging, disease activity assessment, treatment planning, and prognosis evaluation.

Being tested
PET/CT scans
Keywords
Malignant Neoplasm, PET/CT, Non-Small Cell Lung Cancer, Pulmonary nodules
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Multiple Pulmonary Nodules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET/CT scansDiagnostic 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.

Study groups in NCT07487883
Study groupRoleWhat they receive
CDH3-targeted PET in lung malignant tumorsParticipant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-CDH3 PET/CT scans within 1 week.
Receives: Diagnostic Test: PET/CT scans

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 6 weeks

Secondary outcomes (4)
  1. Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT

    Comparison of maximum standardized uptake value (SUVmax) of primary and metastatic lesions between 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT.

    Measured: up to 6 weeks

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

    Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT.

    Measured: up to 6 weeks

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

    Evaluation of the correlation between maximum standardized uptake value (SUVmax) derived from 68Ga-TOI-1 PET/CT and CDH3 expression level measured by immunohistochemistry (IHC) as H-score (combining staining intensity and percentage of positive cells) in tumor tissue samples.

    Measured: up to 6 weeks

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

    Evaluation of the correlation between mean standardized uptake value (SUVmean) derived from 68Ga-TOI-1 PET/CT and CDH3 expression level measured by immunohistochemistry (IHC) as H-score (combining staining intensity and percentage of positive cells) in tumor tissue samples.

    Measured: up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start18 Mar 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07487883
Sponsor's protocol ID
92259303
Status last verified
Mar 2026
First submitted
2 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37019717
  • 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.

    PubMed 34431971
  • 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.

    PubMed 33221195
  • 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.

    PubMed 37683638
  • 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.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer and Malignant Neoplasm, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kezhong Chen, MD (+86-010-88325983, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors. (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07487883, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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