New method to tell apart benign and malignant lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational clinical trial aims to develop a novel approach for distinguishing between benign and malignant pulmonary nodules using a combination of blood metabolomic analysis and artificial intelligence (AI) image analysis. Participants with suspected malignant nodules will provide peripheral blood samples, which will be analyzed through mass spectrometry to characterize metabolites. The study will categorize nodules based on CT imaging and construct a classification model using machine learning algorithms to enhance diagnostic accuracy. The ultimate goal is to improve early diagnosis of lung cancer by accurately identifying the nature of pulmonary nodules.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years;
* CT imaging shows the presence of pulmonary nodule \<3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed;
* Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2;
* Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine \<178μmol/L;
* Subjects must have the ability to understand and sign the informed consent in writing voluntarily.

Exclusion Criteria:

* Imaging examination have suggested the possibility of metastasis at other sites;
* ≥2 target lesions with different type categorized by density;
* History of malignant disease;
* Severe vascular lesions within the last 3 months, or known significant active infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled;
* The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.;
* History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent;
* Pregnant or breastfeeding women;
* Other conditions deemed by the investigator to be unsuitable for enrollment.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Guangying Zhu — China-Japan Friendship Hospital
• Study coordinator: Guangying Zhu, doctor
• Email: zryyfa@163.com
• Phone: +86-010-84205381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.