Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope

Study Overview
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Brief Summary
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The aim of this study is to verify a new microscopic technique in diagnosing patients suspected of lung cancer. Patients will undergo navigational bronchoscopy 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.

Official Title
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Validation and Added Clinical Value of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist | 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. | 48 months | 
| The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm. | 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). | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to obtain a diagnosis from HHG microscopy images as judged during the procedure (rapid on-site) by the cyto-technician or pathologist. | Accuracy of Rapid-On site Assessment (ROSE) of HHG microscopy obtained images when compared against golden standard routinely used ROSE technique in navigation bronchoscopy Accuracy of Rapid-On site Assessment (ROSE) of HHG microscopy obtained images when compared against golden standard routinely used frozen wedge assessment in cardiothoracic surgery. | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Navigation Bronchoscopy, Higher harmonic generation microscopy, Artificial intelligence, Diagnostics