Validation of optical frequency domain imaging (OFDI) bronchoscopy as a diagnostic imaging modality to characterize pulmonary lesions

Pulmonologists are increasingly confronted with endobronchial and parenchymal
lesions that are suspected for malignancy. A major cause for this is the
increase in radiological imaging of the thorax for lung cancer screening
purposes and in the workup of other diseases (i.e. pulmonary embolism,
infection and other cancers). Invasive diagnostic procedures to characterise
these lesions, like biopsy or surgical resection, are not without risk. The
alternative, follow-up by computed tomography, takes up to two years to
complete, thereby causing uncertainty for patients and exposing them to
radiation and delay of treatment in case a lesion is malignant. Recently we
developed a new bronchoscopic catheter that incorporates an imaging technique
called optical frequency domain imaging (OFDI). This technique enables the
characterization of pulmonary lesions at microscopic resolution.

To validate OFDI bronchoscopy as a diagnostic imaging modality to characterize
pulmonary lesions.

non-randomized non-blinded, non-sham controlled pilot study.

OFDI is a minimally invasive technique. The catheter is blunt and does not
penetrate the mucosa, but only gently comes in contact with the mucosa. The
bronchoscopic procedure will be done as part of routine clinical care. The
extra time needed to image the lesion with OFDI is estimated to be 5 minutes.