Trial results for a study investigating Needle-Based Confocal Laser Endomicroscopy for the diagnosis of Lung Cancer were posted on ClinicalTrials.gov on 2025-09-17. The study was officially TERMINATED, having enrolled 3 participants.
Background
Lung cancer remains a leading cause of cancer-related mortality, necessitating early and accurate diagnosis. Peripheral pulmonary nodules often require invasive procedures for definitive diagnosis. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) is a common diagnostic procedure. This trial explored needle-based confocal laser endomicroscopy (nCLE), a high-resolution imaging technique, combined with fluorescein, to enhance real-time cancer detection during endoscopy and improve diagnostic accuracy for lung cancer in patients with these nodules.
Trial design
This study, designated as Phase NA, was designed to compare the diagnostic utility of adding needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) alone. The trial focused on the diagnosis of Lung Carcinoma in patients presenting with peripheral pulmonary nodules. A total of 3 participants were enrolled before the study was TERMINATED. The intervention involved two arms: Arm I utilized EBUS TBNA alone, while Arm II incorporated EBUS TBNA with nCLE and fluorescein.
Key results
The trial reported per-patient diagnostic yield for both study arms:
- For Arm I (EBUS TBNA), the per-patient diagnostic yield was reported as 0 Participants in one measurement and 2 Participants in another.
- For Arm II (EBUS TBNA, nCLE, Fluorescein), the per-patient diagnostic yield was reported as 1 Participant in one measurement and 0 Participants in another.
What this means
The posted results for this terminated study offer very limited data on the per-patient diagnostic yield of nCLE and fluorescein combined with EBUS TBNA for lung cancer diagnosis. With only 3 participants enrolled and conflicting diagnostic yield figures reported, no definitive conclusions can be drawn regarding the efficacy or benefit of this investigational approach. The trial's termination further limits the interpretability of these early findings, suggesting the need for more extensive future research to properly evaluate nCLE in this diagnostic context.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study "Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules" were posted on 2025-09-17 on clinicaltrials.gov.