The Novel Special Light for Endotracheal/Bronchial Lesions.

NCT07036614 | Enrolling By Invitation DMC

• 1 other identifier: SHCHE202409
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center study. The purpose of this study is o evaluate the diagnostic value of special light (TXI, NBI, RDI) in endotracheal/bronchial lesions.

Conditions

Tracheal Disease; Bronchial Disease

Keywords

TXI; NBI; RDI; WLI

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the special light for endotracheal/bronchial Lesions.

  Histopathology will be used as the gold standard. To compare the diagnostic value of the special light (TXI, NBI, RDI) and white light (WLI) in differential diagnosis of benign and malignant luminal lesions.

  1month

Secondary Outcomes (1)

• The diagnostic methods and grading criteria of the special light

  1 month

Study Arms (1)

Patients with endotracheal/bronchial lesions.

Approximately 400 patients who meet the inclusion and exclusion criteria will be enrolled to develop and validate the the Novel Special Light for the diagnosis of endotracheal/bronchial lesions.

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 endotracheal/bronchial lesions scheduled for a bronschoscopy.

You may qualify if:

• Age ≥18 years old;
• Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
• Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
• Patient who has good compliance and sign informed consent;
• The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

You may not qualify if:

• Pregnant or lactating women;
• No endotracheal/bronchial lesions were detected by bronchoscopy;
• Allergic reaction to narcotic drugs in previous medical history;
• The investigator believes that the subject is not suitable for bronchoscopy;
• High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (2)

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

  PMID: 31912902 BACKGROUND

• Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

  PMID: 26808342 BACKGROUND

MeSH Terms

Conditions

Tracheal Diseases; Bronchial Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: January 31, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-01

Locations

CN (1)