Study name: Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope (VALIDIAG)
Host / recruiting sites
Radboud UMC
Enrollment
Recruiting
Design
Observational Model: Case-Only Time Perspective: Prospective Target Follow-up Duration: 20 Years
Intervention
N/A
Key outcome parameters
The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist
The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm.
Key inclusion criteria
ASA physical status 1-3.
Age 18 years or older.
A pulmonary lesion with an indication for diagnostic or therapeutic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.
Key exclusion criteria
Bleeding disorders.
Less than 18 years old.
Inability to consent.
Unfit for navigation bronchoscopy and/or unfit for surgical resection as per guideline recommended care and multi-disciplinary tumor board decision making.
