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

Recruiting now

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT06007261

Run by

Radboud University Medical Center

People needed

250

Starts

2024-01-19

Expected to finish

2027-04-01

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Radboudumc — Nijmegen, Gelderland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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