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

Overview

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.

Primary outcome measures

• Diagnostic yield [Time frame: 6 months after procedure]

Eligibility criteria

Inclusion criteria

• 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. -

Exclusion criteria

• 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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

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

Publications

• 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

Identifiers

NCT: NCT07004946 · CelTouch clinical trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗