Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07004946

Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions

Led by Guangzhou Medical University · Updated on 2025-06-04

286

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study uses CelTouch to explore patients with lung lesions scheduled for lung biopsy. By comparing with preclinical CLE images and pathological images, CLE diagnostic criteria for benign and malignant lung lesions under the microscope will be established; the performance of CLE in diagnosing peripheral lung lesions will be validated through multicenter clinical research; and a CLE atlas for peripheral lung lesions will be constructed to establish a visual classification diagnostic system for peripheral lung lesions. (1) Comparative Study of In Vivo CLE Images and Pathological Images in the Diagnosis of Peripheral Lung Lesions 1. Collect CLE images and histopathological sections of clearly diagnosed peripheral lung lesions. 2. A diagnostic team composed of 1 bronchoscopy expert, 1 pathology expert, and 2 CLE experts will correlate in vivo and ex vivo CLE images of lung lesions with corresponding pathological images, analyze CLE image characteristics of benign and malignant lung lesions, and establish CLE diagnostic criteria for benign and malignant lung lesions. (2) Validation Study of the Diagnostic Performance of Confocal Laser Endomicroscopy in Peripheral Lung Lesions 1. Multicenter screening of corresponding subjects according to inclusion and exclusion criteria, collection of corresponding videos and images during surgery, and recording of observed characteristic images based on pre-established diagnostic characteristics and criteria. 2. The diagnostic team and sub-center representatives (5 in total) will perform offline interpretation of the collected images and videos, and evaluate the diagnostic performance of CLE in peripheral lung lesions using the accurate diagnostic results obtained from postoperative histopathology or 6-month clinical follow-up as the standard. 3. Establishment of a CLE Atlas and Classification System for Lung Lesions (1) Collect large-scale in vivo and ex vivo CLE images and pathological images of clearly diagnosed lung lesions from multiple centers. (2) Select typical in vivo and ex vivo CLE images of lung lesions with the same pathological type and corresponding pathological images, and jointly describe the CLE image diagnostic characteristics by pathology experts and CLE experts to establish a CLE atlas for peripheral lung lesions. (3) Establish a visual classification system for the internal structure of peripheral lung lesions based on the special signs in CLE images of lung lesions.

CONDITIONS

Official Title

Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older with lung lesions detected by chest CT and scheduled for lung biopsy
  • Preoperative CT indicates a bronchus leading to the lesion to be biopsied
  • Able to understand and willing to sign a written informed consent form
Not Eligible

You will not qualify if you...

  • Contraindications to general anesthesia or bronchoscopy
  • Uncorrectable coagulation disorders
  • Unable to stop therapeutic anticoagulants before surgery within an appropriate time
  • Severe liver or kidney dysfunction, cardiovascular or cerebrovascular diseases, or mental illness
  • Pregnant or lactating patients
  • No clear histological or clinical diagnosis
  • Deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Guangzhou, Guangdong, China, 510100

Actively Recruiting

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Research Team

S

Shiyue Li

CONTACT

C

Changhao Zhong

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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