Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging

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.

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Key information

Conditions

Lung Diseases Cancer, Lung Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spatial Frequency Domain Imaging

Device

Resected lung tissue will be removed from the surgical field and labeled with sutures per standard of care. The specimen will then be immediately analyzed using two SFDI devices in the operating room using sterile technique. Each specimen will be recorded up to three times to ensure at least one high fidelity recording is captured. The SFDI data will be analyzed and compared to the official pathology report from the electronic medical record.

Primary outcomes

Markers of native lung parenchyma

Time frame: May 7, 2023 to December 31, 2026

Use SFDI to identify markers of lung nodule vs native lung parenchyma

Secondary outcomes

Cancer identification

Time frame: May 7, 2023 to December 31, 2026

Distinguish cancer vs non-cancer in lung nodules with SFDI

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Acronym: ALCATS

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Aug 12, 2024
Registry last updated: Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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