Confocal laser endomicroscopy (CelTouch) to diagnose peripheral lung lesions

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

We will test whether confocal laser endomicroscopy (CelTouch) can tell benign from malignant peripheral lung lesions in adults who are scheduled for lung biopsy.

Quick facts

• Study type: Observational
• Enrollment: 286 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guangzhou Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07004946 on ClinicalTrials.gov

What this trial studies

This observational project will collect in vivo CLE images with the CelTouch probe from adults who have peripheral pulmonary lesions and are scheduled for bronchoscopic or biopsy procedures. Collected CLE images will be directly compared with corresponding histopathology and preclinical CLE images by a multidisciplinary diagnostic team consisting of bronchoscopy, pathology, and CLE experts. The team will identify CLE image features that distinguish benign from malignant lesions and construct a CLE atlas and visual classification system for peripheral lung lesions. Performance metrics such as sensitivity and specificity will be calculated to validate the proposed diagnostic criteria.

Who should consider this trial

Good fit: Adults aged 18 or older with peripheral lung lesions seen on CT, a bronchus leading to the lesion, and who are scheduled for lung biopsy and can give informed consent are ideal candidates.

Not a fit: People who are pregnant or lactating, cannot undergo bronchoscopy or anesthesia, have uncorrectable bleeding risk, severe organ dysfunction, or no clear histological/clinical diagnosis are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could provide near-real-time microscopic diagnosis during bronchoscopy, potentially reducing repeat biopsies and speeding treatment decisions.

How similar studies have performed: Smaller prior pulmonary CLE studies have shown promising ability to differentiate benign and malignant airway lesions, but diagnostic criteria for peripheral lung lesions remain limited and this work builds on preliminary evidence.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163 — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Shiyue Li

Conditions Peripheral Pulmonary Lesion; peripheral pulmonary lesion