Validation of a new microscopic technique for diagnosing early-stage lung cancer
Validation and Added Clinical Value of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope
This study is testing a new imaging technique to see if it can help doctors diagnose early-stage lung cancer more accurately and quickly during procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06007261 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a novel microscopic technique using higher harmonic generation microscopy for diagnosing patients suspected of having lung cancer. Patients will undergo navigational bronchoscopy or surgical resection as part of standard care, with biopsies imaged intraoperatively for rapid assessment. The goal is to enhance the accuracy of lung cancer diagnosis by providing immediate feedback on tissue quality and adequacy during the procedure, which is currently assessed postoperatively through histopathology. This approach could potentially streamline the diagnostic process and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a pulmonary lesion that requires diagnostic evaluation according to clinical guidelines.
Not a fit: Patients with bleeding disorders, those under 18, or individuals deemed unfit for navigational bronchoscopy or surgical resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to faster and more accurate diagnoses of lung cancer, allowing for timely treatment decisions.
How similar studies have performed: While the use of rapid on-site evaluation techniques has been established, the specific application of higher harmonic generation microscopy in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erik HFM van der Heijden, Prof. dr. — Radboud University Medical Center
- Study coordinator: Roel LJ Verhoeven, PhD
- Email: roel.lj.verhoeven@radboudumc.nl
- Phone: 0031627495531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.