Confocal laser endomicroscopy (CelTouch) to diagnose peripheral lung lesions
Official title: Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions
Run by Guangzhou Medical University · NCT07004946 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 286 (estimated) |
| Sponsor | Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 31, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT07004946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Shiyue Li
- Email: lishiyue@gird.cn
- Phone: 02081566640
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.