Clinical trial · Observational
Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope
Validation and Added Clinical Value of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist
- timeFrame
- 48 months
- description
- 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.
- measure
- The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm.
- timeFrame
- 48 months
- description
- 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).
Secondary outcomes (1)
- measure
- The ability to obtain a diagnosis from HHG microscopy images as judged during the procedure (rapid on-site) by the cyto-technician or pathologist.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available