Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope
Recruiting · NCT06007261 · Observational (researchers observe without assigning treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Radboudumc - Nijmegen, Gelderland, Netherlands