Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging

NCT06549088 | Enrolling By Invitation

• 1 other identifier: 2767
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Cancer, Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cancer identification

  May 7, 2023 to December 31, 2026

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Lung Diseases; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: August 7, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)