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

NCT07004946 | Recruiting DMC

• 1 other identifier: CelTouch clinical trial
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Collect CLE images and histopathological sections of clearly diagnosed peripheral lung lesions.
2. 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.
3. 3.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.
4. 4.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.
5. 5.Establishment of a CLE Atlas and Classification System for Lung Lesions

Conditions

Peripheral Pulmonary Lesion

Keywords

peripheral pulmonary lesion

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  diagnostic yield=(The number of cases with a definitive diagnosis / The total number of cases enrolled in the trial) × 100%

  6 months after procedure

Study Arms (1)

Confocal laser endomicroscopy group

Utilize confocal laser endomicroscopy for the examination of peripheral lung lesions in patients.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. All subjects have completed CelTouch examination 2. Each subject has obtained a clear histological diagnosis or clinical follow-up diagnosis for 6 months

You may qualify if:

• Aged ≥18 years, with lung lesions detected by chest CT and scheduled for lung biopsy;
• Preoperative CT indicates the presence of a bronchus leading to the lesion to be biopsied;
• Able to understand and willing to sign a written informed consent form. -

You may not qualify if:

• Those with contraindications to general anesthesia or bronchoscopy;
• Patients with uncorrectable coagulation disorders;
• Unable to discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
• Patients with severe liver or kidney dysfunction, cardiovascular and cerebrovascular diseases, mental illnesses, etc.;
• Pregnant or lactating patients;
• Those without a clear histological or clinical diagnosis;
• Subjects deemed unsuitable by the investigator. -

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510100, China

RECRUITING

Related Publications (1)

• Wijmans L, Yared J, de Bruin DM, Meijer SL, Baas P, Bonta PI, Annema JT. Needle-based confocal laser endomicroscopy for real-time diagnosing and staging of lung cancer. Eur Respir J. 2019 Jun 20;53(6):1801520. doi: 10.1183/13993003.01520-2018. Print 2019 Jun.

  PMID: 31023849 BACKGROUND

Central Study Contacts

Shiyue Li

CONTACT

02081566640; lishiyue@gird.cn

Changhao Zhong

CONTACT

+8613570290214; vast1982@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)