Optical Biopsy for Peripheral Pulmonary Lesions

NCT06457087 | Not Yet Recruiting

• 1 other identifier: SHCHE202402
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Pulmonary Lesions

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs

  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.

  6 months post-procedure

Secondary Outcomes (4)

• Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs

  6 months post-procedure

• positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs

  6 months post-procedure

• Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs

  6 months post-procedure

• Incidence of complications

  1 month post-procedure

Study Arms (1)

Patients with peripheral pulmonary lesions

A total of 150 patients with peripheral pulmonary lesions who meet the inclusion and exclusion criteria will be prospectively enrolled, of which 100 patients will be used for the development of CLE interpretation criteria, and 50 patients will be used for the validation of the criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral pulmonary lesions scheduled for transbronchial lung biopsy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)