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Recruiting NCT06007261

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

◆ AI Clinical Summary

This study tests a new microscope technology that can quickly examine lung tissue samples during procedures you're already having for suspected lung cancer. The microscope uses special imaging to help doctors see cancer more clearly and make faster diagnoses.

Key Objective: This trial tests whether a new rapid imaging technique can improve the speed and accuracy of lung cancer diagnosis during routine procedures.

Who to Consider: Patients undergoing bronchoscopy or surgical procedures for suspected lung cancer who want to help advance diagnostic imaging technology should consider enrolling.

Trial Parameters

Condition Lung Cancer
Sponsor Radboud University Medical Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 250
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-19
Completion 2027-04

Brief Summary

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 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.

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