NCT03376971

Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy

Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.

Detailed description

PRIMARY OBJECTIVES: I. Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy. II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples. OUTLINE: Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.

Conditions

• Lesion
• Lung Cancer
• Diagnoses Disease

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo lung biopsy
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-07-26
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2017-12-19
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States