Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging

• Conditions: Lung Diseases; Cancer, Lung

• Registration Number: NCT06549088
• Lead Sponsor: University of California, Irvine

Brief Summary

This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Patients who have confirmed or suspected lung nodules and who are undergoing resection of those nodules will be recruited for the study. Study participants will undergo standard of care lung nodule resection in the operating room, and the resected specimen will be imaged using the SFDI device immediately after removal from the surgical field. The data captured from the SFDI images will then be compared to the pathology findings to identify optical properties of normal and cancerous lung tissue. Because the intervention is conducted on resected biospecimens, this study yields minimal risk to participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-07
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-08-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Greater than or equal to 18 years old
• Suspected or confirmed lung nodule on diagnostic imaging
• Undergoing lung resection using an open, endoscopic, or robotic approach
• Standard of care orders placed for a pathology assessment of resected lung tissue
• Adults undergoing lung resection for a lung mass

Exclusion Criteria

• <18 years old
• Pregnant females and incarcerated individuals
• No standard of care orders to obtain a pathology assessment
• RUSH pathology order for resected lung tissue
• Any condition where the principal investigator determines to impact patient safety or quality of care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Markers of native lung parenchyma	May 7, 2023 to December 31, 2026	Use SFDI to identify markers of lung nodule vs native lung parenchyma

Secondary Outcome Measures

Name	Time	Method
Cancer identification	May 7, 2023 to December 31, 2026	Distinguish cancer vs non-cancer in lung nodules with SFDI

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States