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Studieoverzicht

Study name: Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope (VALIDIAG)

NCT Id NCT06007261
Host / recruiting site 1 Radboud UMC Enrollment Recruiting
Design

Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-up Duration: 20 Years
Intervention

N/A
Key outcome parameters
  • The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist
  • The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm.
Key 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.
Key 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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