Clinical trial · Observational
New Method to Differentiate Benign and Malignant Pulmonary Nodules.
A New Method to Differentiate Benign and Malignant Pulmonary Nodules by Mass Spectrometry Combined With Artificial Intelligence.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (\<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- A. pure ground-glass nodule
- description
- Patients with pure ground-glass nodules (GGNs).
- label
- B. part-solid nodule
- description
- Patients with part-solid nodules (PSNs).
- label
- C. solid nodule
- description
- Patients with solid nodules (SNs).
Primary outcomes (1)
- measure
- Establish an model for differentiating lung nodules.
- timeFrame
- 6 months
- description
- To establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) image analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available