Clinical Trial Radar

Name: A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors
Creator: Peking University People's Hospital
Published: 2026-03-23
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07487883 for Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors 80

Not yet recruiting

Clinical Trial NCT07487883 is an observational study for Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT and is currently not yet recruiting. Enrollment is planned to begin on 15 March 2026 and continue until the study accrues 80 participants. Led by Peking University People's Hospital, this study is expected to complete by 30 July 2027. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.

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, targeti...Show More

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 worldwid...Show More

Official Title

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

Conditions

Non-Small Cell Lung CancerMalignant NeoplasmPulmonary NodulesPET/CT

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.

Other Study IDs

92259303

NCT ID Number

NCT07487883

Start Date (Actual)

2026-03-15

Last Update Posted

2026-03-23

Completion Date (Estimated)

2027-07-30

Enrollment (Estimated)

Study Type

Observational

Status

Not yet recruiting

Keywords

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

Arms / Interventions

Participant Group/Arm

Intervention/Treatment

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.

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 c...Show More

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT.	up to 6 weeks
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.	up to 6 weeks
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.	up to 6 weeks

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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.

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.

Peking University People's Hospital

Study Responsible Party

Chen KeZhong, Principal Investigator, Director of Thoracic Oncology Institute, Peking University People's Hospital

Study Central Contact

Contact: Kezhong Chen, MD, +86-010-88325983, [email protected]

Contact: Yutao Li, MD, +86-010-88325754, [email protected]

1 Study Locations in 1 Countries

China

Beijing Municipality

Peking University People's Hospital, Beijing, Beijing Municipality, 100044, China

Kezhong Chen, MD, Contact, +86-010-88325983, [email protected]

Yutao Li, MD, Contact, +86-010-88325754, [email protected]

Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors 80

Inclusion Criteria

Exclusion Criteria