Mauna Kea Technologies SA announced that the results of the first in human clinical study combining nCLE and robotic-assisted bronchoscopy (Clinicaltrials.gov: NCT04441749) have been published in the international peer-reviewed journal Respirology(1) . This clinical study, co-funded by the Lung Cancer Initiative at Johnson & Johnson(2), combines needle-based confocal laser endomicroscopy and robotic-assisted bronchoscopy using both Cellvizio(R) and the Monarch(TM) Platform from Ethicon(3) for the diagnosis of peripheral lung nodules. Twenty patients with a median lung nodule size of 14.5mm (range 8-28mm) were enrolled.

This study demonstrated that robotic-assisted bronchoscopic nCLE-imaging in small peripheral lung lesions is feasible and safe and provides real-time feedback on correct needle positioning. Bronchoscopic nCLE-imaging provided tool-in-nodule confirmation in 19 of 20 patients (95%) whereas corresponding rapid on-site evaluation (ROSE) confirmed representative material in only 9 of 20 patients (45%) and no complications were reported during the study. With nCLE real-time in vivo cellular imaging feedback, the needle was repositioned in 45% of the patients (9/20 patients) to reach a diagnostic yield across all nodule sizes and locations of 80%.

Of the 17 patients with malignancy, 16 (94%) had the final diagnosis of lung cancer confirmed by nCLE imaging, including two patients with negative TBNA and biopsies.