Optical Biopsy for Peripheral Pulmonary Lesions
- Conditions
- Peripheral Pulmonary Lesions
- Registration Number
- NCT06457087
- Lead Sponsor
- Shanghai Chest Hospital
- Brief Summary
The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.
- Detailed Description
CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial lung biopsy, CLE has the potential to provide real-time non-invasive diagnosis of PPLs ("optical biopsy"). In this study, we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs. We will compare the results of the "optical biopsy" with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs. In addition, we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Patients older than 18 years.
- Chest CT shows peripheral pulmonary lesions (peripheral pulmonary lesions are lesions beyond the segmental bronchi that are invisible during bronchoscopy), and transbronchial biopsy is considered necessary and feasible.
- Patients who have good compliance and sign informed consent.
- Patients with known allergy for fluorescein.
- Pregnant or lactating women.
- Patients with contraindications of bronchoscopy.
- The investigators believe that patient has other conditions that are not suitable for the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs 6 months post-procedure Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE interpretation criteria divided by the total number of lesions.
- Secondary Outcome Measures
Name Time Method Incidence of complications 1 month post-procedure Complications mean a composite of procedure related adverse advents during and after the operation.
Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs 6 months post-procedure Sensitivity is defined as the number of lesions correctly identified as malignant using our proposed CLE interpretation criteria divided by the total number of malignant lesions. Specificity is defined as the number of lesions correctly identified as benign using our proposed CLE interpretation criteria divided by the total number of benign lesions.
positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs 6 months post-procedure The positive predictive value is the percentage of true malignant lesions among all lesions identified as malignant using our proposed CLE interpretation criteria. The negative predictive value is the percentage of true benign lesions among all lesions identified as benign using our proposed CLE interpretation criteria.
Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs 6 months post-procedure Different types of PPLs include different types of common malignant PPLs (e.g., adenocarcinoma, squamous cell carcinoma, small cell lung carcinoma, etc.) and different types of common benign PPLs (e.g., inflammation, tuberculosis, fungal infection, etc.). Diagnostic accuracy is defined as the number of lesions correctly identified as a specific disease using our proposed CLE interpretation criteria divided by the total number of lesions.
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China