Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging

NCT ID: NCT06549088

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Spatial Frequency Domain Imaging

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Hari Keshava

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

2767

Identifier Type: -

Identifier Source: org_study_id