NCT05517083

Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer

Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).

Detailed description

This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.

Conditions

• Non Small Cell Lung Cancer
• EGFR Gene Mutation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultarthin bronchoscopy with intratumoral washing	Each subject with NSCLC will undergo bronchooscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-09-30
• Completion: 2024-12-31
• First posted: 2022-08-26
• Last updated: 2025-08-20

Locations

1 site across 1 country: South Korea