Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging (ALCATS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Diseases; Cancer, Lung
• Intervention / Treatment: Device: Spatial Frequency Domain Imaging

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults undergoing surgical resection of a suspected or confirmed lung mass.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers of native lung parenchyma	Use SFDI to identify markers of lung nodule vs native lung parenchyma	May 7, 2023 to December 31, 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer identification	Distinguish cancer vs non-cancer in lung nodules with SFDI	May 7, 2023 to December 31, 2026

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Lung Neoplasms
• Other Study ID Numbers: 2767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No