The aim of this study is to verify a new microscopic technique in diagnosing patients suspected of lung cancer. Patients will undergo navigational bronchoscopy or surgical resection as a part of standard of care. Biopsies taken during this procedure will be imaged for a few minutes with a higher harmonic generation (HHG) microscope, after which the material is taken to the pathology department for histopathology assessment, which is currently the golden standard for diagnosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
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.
Primary outcome measure(s)
The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist — 48 months Accuracy of HHG microscopy obtained and assessed images for diagnosing pathology as compared against golden standard routine clinical follow up pathology tissue evaluation techniques (H\&E staining and if used, additional stains), as judged by the pathologist.
The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm. — 48 months Accuracy of HHG microscopy image based AI algorithm for autonomous diagnosis of pathology as compared against diagnosis of conventional golden standard routine clinical follow up pathology tissue evaluation techniques (H\&E staining and if used, additional stains).
Trial sites (1)
Facility
City
Region
Status
Radboudumc
Nijmegen
Gelderland
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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